Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity

summary: Regulations codified at 42 CFR 493.17, implementing the

Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law

100-578, require that the Secretary provide for the categorization of

specific laboratory test systems, assays, and examinations by level of

complexity. The criteria for such categorizations also are set forth in

those regulations.

A compiled list of approximately 12,000 specific clinical

laboratory test systems, assays, and examinations categorized by level

of complexity was published in the Federal Register on July 26, 1993

(58 FR 39860). This notice contains responses to the comments submitted

on those aspects of the July 26, 1993 publication that were subject to

comment. This Notice also announces approximately 2900 additional test

systems, assays, and examinations that have been categorized since the

publication of the compiled test list. Included in this list of

additional categorizations are those test systems which received 510(k)

or premarket approval from the Food and Drug Administration (FDA)

during the period from September 1, 1992 to March 15, 1995. Also

included are additional test systems that were cleared prior to that

period and noted by commenters as missing from the compiled test list.

dates: Effective date: The categorizations on this list were effective

on the date of the test categorization notification letter sent to the

manufacturer. Written comments on the tests initially categorized in

this Notice will be considered if they are received at the address

indicated below, by no later than 5 p.m. on June 14, 1995. CDC reserves

the right to reevaluate and recategorize tests based on the comments

received in response to this Notice.

addresses: Comments on the categorization of tests initially

categorized in this Notice should be addressed to Public Health

Service, Attention: CLIA Federal Register Notice, Centers for Disease

Control and Prevention, Mail Stop F-11, 4770 Buford Highway, NE.,

Atlanta, Georgia 30341-3724.

Due to staffing and resource limitations, we cannot accept

facsimile (FAX) copies of comments. Nor can we accept comments by

telephone.

for further information contact: Rosemary C. Bakes-Martin, (404) 488-

7655.

supplementary information: All requests for recategorization received

during the 30 day comment period provided in the July 26, 1993 Federal

Register notice (59 FR 39860) resulted in extensive review of available

product information and the original complexity scoring for the

individual test system, assay, or examination under consideration. If

the requestor submitted new information, the test system was rescored

taking into account the new information. Any changes in categorization

or reasons for not making changes are addressed in this Notice under

the section Comments and Responses.

Comments in response to the July 26, 1993 Notice, that requested

additional laboratory tests be waived of specific CLIA requirements,

were deferred in light of the moratorium declared on classifying

testing devices as waived tests on February 18, 1993. The CDC lifted

the moratorium on waiver on December 19, 1994, and has now resumed

reviewing requests for waiver status. On the date that the moratorium

was lifted, a letter was sent to manufacturers of laboratory testing

devices, that included guidelines that manufacturers may use to submit

their requests for waiver. Requests for waiver will be evaluated in the

order in which they are received.

The public has requested that test categorization information be

made available electronically. CDC is providing computer access to this

information via the Internet. For further information regarding this

capability, please call (404) 488-7655.

Comments and Responses

Comment: A manufacturer requested clarification of what determines

whether a testing device is subject to CLIA regulations. The commenter

had concerns about measuring versus monitoring devices and ``in-vitro''

versus ``in-vivo'' testing.

Response: All clinical laboratory tests performed on materials

derived from the human body for the purpose of providing information

for the diagnosis, prevention, or treatment of any disease, or the

assessment of the health of, human beings are subject to CLIA

regulations. The term ``derived from the human body'' refers to any

specimen that is expelled from the human body, withdrawn by procedures

such as phlebotomy, or, in the case of blood, diverted from the

circulatory path. The circulatory path is defined as either the body's

normal circulatory blood flow or a path established by a life-

sustaining apparatus such as the ``heart-lung'' machine. To be

considered as a normal circulatory path, the ``heart-lung'' machine

blood flow must be for the purpose of sustaining life and not for the

purpose of performing testing. The examination of materials removed or

diverted from either of these circulatory paths (normal or life

sustaining) meets the definition of ``in-vitro'' testing and is subject

to the CLIA regulations. An example of this type of procedure is ``ex-

vivo'' blood gas testing performed on a specimen diverted or removed by

means of an indwelling radial catheter. (This indwelling catheter has

not been established for the purpose of sustaining life and is outside

the circulatory flow.) All tests that meet the definition of ``in-

vitro'' testing are subject to CLIA regulations. ``In-vivo'' testing,

i.e. testing that is not removed or diverted from a normal or life

sustaining circulatory path, is not subject to CLIA regulation at the

present time. An example of this type of testing is pulse oximetry.

Please note, however, that we are presently investigating the

definitional and technical issues, and necessary revisions to the

regulations that would make ``in-vivo'' testing subject to CLIA. Should

it be determined at a later date that it is subject to CLIA, proper

notice and opportunity for public comment will be provided before this

testing is subject to CLIA regulation.

The context in which the test results are being evaluated, i.e.

monitoring versus measurement, is not a consideration for test

complexity.

Comment: A few manufacturers commented that some of their test

systems should not be categorized for certain analytes because the

company did not supply the reagents for performing these tests on the

instruments listed.

Response: Although the company which manufactures a test system may

not have developed an assay procedure for a particular analyte, it is

quite possible that another company could design an assay procedure

that has been cleared by the FDA for use on the test system. In such a

situation, the analyte will be listed as being available on the test

system. If the assay developed by the reagent manufacturer does not

perform as it should on the test system, it is the responsibility of

the laboratory performing the testing or the manufacturer of the test

system to inform the FDA.

[[Page 25945]]

Comment: Abbott Laboratories commented that the compiled list

published on July 26, 1993 in the Federal Register did not specifically

state whether the analytes Toxoplasma gondii Antibodies,

Cytomegalovirus Antibodies, and Rubella Antibodies on the Abbott IMX

were for determining IgG, IgM, or total antibodies.

Response: The analyte nomenclature for antibodies to

cytomegalovirus, toxoplasmosis, and rubella does not specify that the

antibodies are total, IgG, or IgM antibodies. In those instances where

a kit is used to identify the antibodies, the test system name will

frequently specify that the antibodies being detected are either total

antibodies, or IgG or IgM specific antibodies. When the test system

name does not include the specific antibody, as is the case with the

automated analyzers, then the generic nomenclature for the antibody can

refer to total or specific antibodies. We do not see this nomenclature

as a problem because the test complexity for the procedure will be the

same regardless of whether the antibodies being detected are total are

specific antibodies.

Comment: One organization, after learning of the recommendation by

the Clinical Laboratory Improvement Advisory Committee (CLIAC) and

subsequent move of some HDL procedures from high to moderate

complexity, requested recategorization of HDL procedures back to high

complexity. The organization felt that all HDL procedures should

receive a complexity score of ``3'' for the criteria ``Training and

Experience'' and ``Calibration, Quality Control or Proficiency Testing

Materials.'' Another manufacturer requested that numerous HDL

procedures be recategorized from high complexity to moderate

complexity. Other commenters indicated that based upon the process for

recategorization of 16 HDL procedures from high to moderate complexity

announced in the July 26, 1993 Notice, there were some inconsistencies

in the application of this process to other HDL procedures. The

commenters felt that the reagent preparation requirements for some of

the HDL procedures that remained high complexity were not sufficiently

complicated to warrant a higher score than those HDL procedures that

were recategorized to moderate complexity. The commenters requested

that the scores of these HDL procedures be lowered from ``2'' to ``1''

in the criterion ``Reagents and Materials Preparation'' and that these

procedures be recategorized from high complexity to moderate

complexity.

Response: In response to the continuing concerns regarding the

categorization of HDL cholesterol, CDC once again reassessed the

assigned scores for HDL as performed by automated methods. The original

CLIAC discussion had focused on the question of the training and

experience, and interpretation and judgment necessary for the analyst

to make appropriate decisions (e.g., evaluation of the supernatant's

turbidity in the pretreatment precipitation step) during the testing

process. It was on this issue that CDC determined that analyst

interaction was of a lesser degree for some automated methods than for

others. Therefore, following the CLIAC recommendation for reevaluation

of these score assignments, some HDL procedures were recategorized from

high to moderate complexity. In response to the comments on the July

26, 1993 test list that announced this group of recategorizations, we

have reevaluated all HDL procedures for consistency in applying the

criteria ``Reagents and Materials Preparation''. Under this criteria, a

score of ``1'' is assigned when the manufacturer provides that analyst

with an automated method of adding quantitative amounts of

precipitating reagent to the sample so that analyst intervention is

minimal, or when the manufacturer provides the analyst with a dedicated

tube containing a single precipitating reagent. As a result of

reevaluating the application of this criteria, the following HDL

procedures have been recategorized from high complexity to moderate

complexity: Abbott TDX, Abbott TDX FLX, Abbott Vision Non Whole Blood

HDL Procedure, and the BioAutoMed ASCA.

Comment: One commenter recommended the recategorization of

``large'' hematology analyzers and microscopy procedures from moderate

to high complexity.

Response: Using the seven criteria established for categorization,

automated hematology analyzers, in general, scored as moderate

complexity. Although the large automated instruments used in hematology

apply multiple principles in their operation, the instruments do not

require extensive analyst intervention or highly specialized knowledge

for operation. Microscopy procedures were also categorized by

complexity using the criteria established for test categorization.

Those procedures which do not require an extensive level of knowledge

or training to perform the evaluation, or do not require an extensive

level of judgment or interpretive skill to recognize or enumerate the

cellular elements under evaluation, generally scored as moderate

complexity.

Comment: One manufacturer requested recategorization of some alpha-

fetoprotein procedures from high complexity to moderate complexity.

Response: Material serum alpha-fetoprotein (AFP) procedures require

extensive training, interpretation and judgment. The analyst must use

patient information related to the weeks of gestation in conjunction

with the procedure value to obtain a reportable result. Amniotic fluid

specimens for AFP may require preanalytic testing to determine the

presence of interfering substances which can lead to result

misinterpretation or they may need manipulation of the sample to

produce a clear supernatant. Extensive interpretive and judgment skills

are also necessary to resolve technical problems, such as improper

specimen collection, or determine the need for repeat testing. All of

these considerations are in addition to those related to the

methodology of the testing procedure. At the present time, all

procedures for maternal serum AFP and amniotic fluid AFP score in the

high complexity category.

Comment: On professional organization voiced support for the high

complexity scores given to any test that involves the interpretation of

cultures and requires multiple steps for the achievement of accurate

results. This organization suggested that other tests now categorized

as moderate complexity should be categorized as high complexity for the

same reasons. The example given was the direct Coombs test, which the

organization indicated would yield a false negative result if the

patient read blood cells were washed insufficiently.

Response: We appreciate the organization's statement of support

concerning the categorization scores of microbiology culture methods.

In regard to the direct antiglobulin test (DAT), or direct Coombs, we

feel that this assay is appropriately categorized as moderate

complexity since the procedural skills are easily acquired, the

reagents are stable and ready to use, and limited knowledge and

judgment is required. The CLIA regulations to do relieve the laboratory

of its responsibility to evaluate the competency of its staff or

provide sufficient training on supervision for the correction of any

technical deficiencies. Training on proper wash techniques to prevent

false negative DAT results should be an integral part of the training

of all analysts performing these procedures. We do not feel that the

degree of [[Page 25946]] decision making, interpretation, and judgment

required to perform a DAT approaches the level required to isolate and

identify organisms from culture.

Comment: Several commenters expressed confusion concerning the

categorization of rapid strep test kits. Some referred to them as high

complexity procedures.

Response: Most of the tests that detect streptococcal antigen

directly from a throat swab are categorized as moderate complexity

tests. They require some knowledge, training and judgment to accurately

perform the procedure. They are not categorized as high complexity

tests because they do not require the level of knowledge, training,

experience and interpretative skill that is required of a high

complexity procedure such as isolation and identification of an

organism from culture.

Comment: Several commenters requested that throat and urine

cultures, and urine susceptibility testing be recategorized from high

to moderate complexity. A few other commenters agreed with high

complexity categorization of microbiology cultures due to the advanced

level of interpretation, judgment, knowledge, and experience required

to obtain an accurate result when performing these procedures.

Response: Isolation, identification, and susceptibility testing of

microorganisms from culture is a complex process regardless of the

source of the culture. It requires significant knowledge, training, and

interpretation for the selection and performance of the individual test

components in this process, which may include staining for microscopic

evaluation, subculturing, and performing the appropriate biochemical

analyses. Taking these factors into consideration when scoring for

complexity, these test systems are appropriately categorized as high

complexity.

Comment: One commenter asked whether the use of general

microbiology culture media, such as sheep blood agar, was categorized.

There has also been some confusion as to whether inoculation of primary

culture media or the determination of a ``No growth'' final culture

result is considered a high complexity test.

Response: Primary inoculation of microbiology culture media (e.g.

blood agar, chocolate agar, MacConkey agar, heart infusion broth) is

not considered a complete test system under the CLIA regulations. The

process of isolation and identification from the primary culture is

considered a total test system. The inoculation of the media becomes

part of the test system when the primary media is observed to determine

whether growth is present after an incubation period. We have

previously stated that if a culture is read even to the point of

providing a result of ``No growth'' it is considered to be an

identification from culture, and, therefore, the laboratory reporting

the result must be certified to perform the entire culture procedure.

In response to the confusion as to whether the determination that there

is either growth or no growth on primary culture plates, including the

final reporting of a ``No growth'' culture result, falls into the

moderate or high complexity category, we have created a new test system

designation, (22167) ``Growth/No Growth of Bacteria on Solid Culture

Media'', which is categorized as moderate complexity. This test system

designation applies to a result determined after examining a culture

from any body site, that was initially inoculated on solid culture agar

or media. It does not apply to cultures inoculated into a broth medium

such as heart infusion broth, thioglycollate medium, or to conventional

broth blood cultures. Final reports for this moderate complexity test

system are limited to ``Growth'', ``Growth--referred for identification

or interpretation'', or ``No growth''. A result of ``No growth'' means

that there are NO bacterial colonies on the media after incubation. The

presence of ``normal flora'', contaminants, or any organism not

considered a pathogen could not be interpreted or reported as ``No

growth''.

Individual biochemical tests that are performed as part of the

total identification process (e.g. oxidase, catalase) are not

categorized as separate tests. Those test systems or kits that usually

contain a group of biochemical or serological tests, and result in the

definitive identification of a microorganism are categorized. Several

selective culture media that do not require transfer from the initial

plate, and result in preliminary identification of a specific

microorganism, have been categorized as moderate complexity tests. The

degree of training and experience, judgment and interpretive skills

required to recognize one specific colony type or reaction on these

selective media is significantly less than what is required for

selecting specific colonies from the growth on primary culture plates,

and performing definitive identification tests on pure cultures of

these organisms.

Comment: One commenter requested that all of the test systems for

dermatophytes that have been categorized and published as moderate

complexity should be recategorized as high complexity due to the

advanced level of interpretation, judgment, knowledge, and experience

required to obtain an accurate result.

Response: The test systems for dermatophytes that have been

categorized as moderate complexity are tests performed on selective

media that detect the presence or absence of dermatophytes, but do not

identify these fungi. These test systems require significantly less

knowledge, experience, interpretation, and judgment than high

complexity cultures for isolation and complete identification of fungi,

in which organisms must be transferred and identification procedures

performed. Based on the information we have received to date, we

believe that the test systems for dermatophytes using selective media

are appropriately categorized as moderate complexity.

Comment: Several commenters requested that the following analytes

and test systems be recategorized from moderate to high complexity:

N. gonorrhoeae (from urogenital or rectal only)

Test system--All presumpt. ID using select, media, oxidase, and

gram stain

Streptococcus, group A (from throat only)

Test system--All presumpt. ID w/selective media, hemolysis, and

bacitracin

Response: These two tests for presumptive identification of a

single microorganism on selective media from culture of a specific body

site were placed in the moderate complexity category because the

knowledge, training, interpretation and judgment required is

significantly less than that needed to distinguish multiple organisms

and determine the presence of pathogens, normal flora, or contamination

in a culture initially inoculated on general nonselective culture

media. For these reasons, we disagree with these commenters, and these

tests will remain categorized as moderately complex.

Comment: One commenter requested that Gram stain procedures

performed on endocervical specimens be recatogorized from moderate to

high complexity.

Response: Gram stains from urethral and endocervical smears are

categorized as moderate complexity procedures, while Gram stains from

other sources are categorized as high complexity procedures as

determined by the scoring criteria established for test categorization.

Smears from urethral and endocervical sources do not tend to

[[Page 25947]] contain the variety of microorganisms or cell types that

can be seen on smears taken from other sources. Therefore, the

knowledge, training and experience, interpretation and judgment

required to interpret a Gram stained smear from urethral or

endocervical sources is not as extensive as that required to interpret

gram stain smears from other sources. Although we agree that there is a

difference in the interpretation and judgment required for Gram stained

smears from urethral versus endocervical sources, we do not believe

that difference is sufficient to place the Gram stain evaluations

performed on endocervical smears into high complexity. This issue was

presented to, and discussed by, CLIAC. The CLIAC felt that CDC's

assessment of the level of difficulty for performing the evaluations

was appropriate, thus the Gram stain of endocervical smears will remain

in the moderate complexity category.

Comment: One commenter requested that the MAST CLA-1 Luminometer

System be recategorized from high to moderate complexity. The commenter

noted that this is a different request from earlier correspondence

requesting that the MAST Allergy Densitometer System be recategorized

from high to moderate complexity.

Response: We would like to emphasize that we assess the complexity

of every analyte on each individual instrument and do not categorize

instruments by complexity without analytes. Additionally, the entire

testing process of preanalytic, analytic, and postanalytic steps,

including the process for determination of results, are evaluated for

categorization. Thus the instrument used to read the final results is

not graded independently of the total testing process. The analytes for

which the MAST CLA Allergy System has been categorized as a high

complexity test system are ``allergen specific IgE'' and

``immunoglobulins IgE''.

As in our earlier response regarding the MAST CLA Allergy System,

we maintain that high complexity is the appropriate complexity rating

for the MAST CLA Allergy System. While it is true that there are two

different means to measure test results for this procedure, i.e., by

densitometer or by using the MAST Chemiluminescent Analyzer (CLA-1),

these measuring devices do not significantly change the complexity of

the entire testing process. Substantial training and experience are

required to perform the complete procedure. The steps in the procedure

are manually executed and are performed in the same way except for

result reading and data reduction. Regardless of the reading system

used, the analyst must prepare multiple reagents prior to testing, some

of which require special handling; the process requires manual addition

of specimen to the chamber using a syringe, followed by timed

incubation, multiple wash steps, addition of reagents, a second timed

incubation and more wash steps. It is only after these second wash

steps are completed that the CLA-1 Chemiluminescent Analyzer automates

the photodevelopment, result reading and data reduction, while the

Densitometer system requires manual photodevelopment, followed by

result reading and data reduction on the instrument.

We have reviewed the MAST CLA Allergy System taking into account

both methods of final result determination and have concluded that due

to the knowledge, training and skills necessary to perform the IgE

assays properly, this test system belongs in the high complexity

category. However, for purposes of clarification, we have listed the

system in this Notice in such way that the method of result

determination is clearly specified, and it is now listed twice, as

follows: (40176) MAST CLA Allergy System (densitometer) and (40177)

MAST CLA-1 Chemiluminescent Allergy System. Both are categorized as

high complexity.

Comment: One commenter requested that the Scandipharm CF INDICATOR

SWEAT TEST SYSTEM (CFIS) be given the same status as the physician-

performed microscopy procedures so that access to cystic fibrosis

screening would not be restricted.

Response: The Scandipharm CF INDICATOR SWEAT TEST SYSTEM (CFIS)

does not meet the criteria for physician-performed microscopy

procedures (PPM). The PPM examinations include only specific

microscopic procedures performed on specimens that are derived from

patients as part of the physical examination. We have received numerous

comments suggesting that another level of complexity be established

that is intermediate between waived and moderate complexity. HHS is

taking these suggestions under advisement.

Additions to Waived Category

The Ames Glucometer ENCORE QA Blood Glucose Meter (04423) and the

Ames Glucometer QA Blood Glucose Meter (04422) have been deleted from

the list of moderate complexity tests and have been added to the list

of waived tests. Section Sec. 493.15(c) of the CLIA regulations lists

``blood glucose by glucose monitoring devices cleared by the FDA

specifically for home use'' as waived tests. The Ames Glucometers are

glucose monitoring devices that were recently cleared by the FDA for

home use; therefore, they are now listed as waived tests.

Please note that in this list of additions to the CLIA test

categorization list, we have included the test systems (58311)

Separation Technology STI HemataStat II and (58309) Separation

Technology STI HemataStat Model C70 under the analyte (9581) Spun

Microhematocrit as waived procedures. On previous lists of waived

procedures, we did not list individual test systems capable of

obtaining results for spun hematocrit, but rather listed the all-

inclusive test system designation (04420) ``All Spun Microhematocrit

Procedures''. The two Separation Technology test systems have been

listed in response to requests from the public to clarify that these

test systems are indeed spun microhematocrit procedures. The all-

inclusive test system designation (04420) will continue to be included

on the waived list to indicate that, at the present time, all spun

microhematocrit test systems are waived procedures. We do encourage the

public to contact us if there are questions about whether other

specific test systems meet this definition. In the future, we will

include all test systems by manufacturer's name on the waived list.

Additions

In this publication, we are announcing the categorization of two

laboratory procedures that are normally performed in dental offices.

The dental procedures for (4965) Proteolytic enzymes are listed in the

speciality of General Chemistry, and for (1317) Dental plaque, in

bacteriology.

Corrections

The following corrections to the list of test systems, assays and

examinations published previously in the Federal Register are based on

supplemental information provided by the commenters during the comment

period or as a result of corrections of data entry errors. The CDC

should be notified of any changes in manufacture or test system names

so that these changes can be included in the next published test list.

Scandipharm CF Indicator (58240):

The Scandipharm CF Indicator (58240) (Cystic Fibrosis Sweat Test)

has been deleted from the high complexity category and placed in the

moderate complexity category based upon new [[Page 25948]] information

supplied by the manufacturer regarding the sample collection. Previous

information had indicated that the amount of analyst involvement in the

collection of the sample was more extensive than that indicated in the

new information. Upon evaluation of this information supplied by the

manufacturer, it was determined that the training and experience and

interpretation and judgment required by the analyst to successfully

perform the sample collection is not as extensive as originally

indicated. As a result of the adjustment of scores for relevant

criteria, the Scandipharm CF Indicator now registers a total score that

places it in the moderate complexity category.

International Technidyne Corporation:

As noted in the preamble to the compiled test list, the analyte

heparin was removed from the International Technidyne Corporation

systems because the relevant analytes were either (2539) heparin dose

response (HDR) or (2538) heparin/protamine titration (HPT). These

systems were inadvertently omitted in the compiled test list for the

analytes HDR or HPT. This error has been corrected in the database and

the systems are listed in this Notice under the appropriate analytes.

(2502) HCG, Serum, Quantitative:

The analyte, HCG, Serum, Quantitative, has been clarified as (2502)

HCG, Beta, Serum, Quantitative.

(4945) Protamine Rate Titration (PRT)

The analyte (4945) Protamine Rate Titration for the International

Technidyne Hemochron test systems has been corrected to (4945)

Protamine Response Test (PRT).

MicroProbe Affirm VP Identification Kit (40135) for the detection and

identification of (2212) Gardnerella vaginalis:

Identification of G. vaginalis using the MicroProbe Affirm VP

Identification Kit is categorized as a moderate complexity test, and is

correctly listed as such on page 39879 of the July 26, 1993 Federal

Register notice, in the List of Previously Unpublished Categorizations.

The erroneous listing of this analyte and test system as high

complexity in the compiled test list of categorizations has been

corrected in this Federal Register Notice.

Bio-Scan Bio-Gen:

The manufacturer's name was inadvertently omitted from several

entries for Bio-Gen test systems, listed under (9641) Urine Dipstick or

Tablet Analytes, Nonautomated. These entries have been corrected to

read Bio-Scan Bio-Gen in this notice.

Access Medical Systems ImmunoClone HCG Test (04377):

An entry under HCG, Serum, Qualitative, was incorrectly listed as

Access Medical Systems ImmunoClone (direct Ag/visual) (04311) and has

been revised to read Access Medical Systems ImmunoClone HCG Test

(04377).

bioMerieux Vitek Vidas (07434):

The test system bioMerieux Vitek Vidas (07434) for the analyte

(6111) Thyroxine, Free (FT4) has been revised to Vitek Systems Vidas

(67038) for consistency in the listing of test systems, assays, and

examinations.

Incorrect Test System Codes

Incorrect test system codes were inadvertently assigned to several

systems on the previous test list and have been corrected as follows:

Gen-Probe Legionella Rapid Diag. Systems (including culture) was

incorrectly assigned the test system code (22126). The correct code is

(22160).

Gen-Probe M. Pneumoniae Rapid Diag. Systems (including culture) was

incorrectly assigned the test system code (22127). The correct code is

(22161).

Gull Laboratories RSV-Mab Test (direct antigen) was incorrectly

assigned the test system code (22128). The correct code is (22162).

Seradyn Colorvue--Giardia (direct Ag/visual) was incorrectly

assigned the test system code (58100). The correct code is (58296).

Seradyn Colorvue--Cryptosporidium (direct Ag/visual) was

incorrectly assigned the test system code (58101). The correct code is

(58297).

Deletions

(4023) Myoglobin:

The analyte myoglobin was listed in both the General Chemistry and

Immunology speciality areas. It has been deleted from the Immunology

speciality area.

(0444) Anti-Reticulin Antibodies:

Anti-Reticulin Antibodies on the Scimedx Auto Screen Test System

(58016) has been deleted because it has not been cleared by FDA for use

in the clinical laboratory.

(5503) Respiratory viruses (Influenza A&B, parainfluenza):

The analyte Respiratory viruses (Influenza A&B, parainfluenza) has

been deleted and replaced with the following analytes: (0410)

Adenovirus, (2828) Influenza A, (2829) Influenza B, (4959)

Parainfluenza 1, (4960) Parainfluenza 2, (4961) Parainfluenza 3, and

(5503) Respiratory syncytial virus.

(0456) Antithrombin III (ATIII):

Instrumentation Laboratory IL ACL 100 (28073) has been deleted from

the analyte (0456) Antithrombin III (ATIII) because this analyte is not

available on this system.

(0703) Beta-2 microglobulin:

Du Pont Medical Products aca II (13172) has been deleted from the

analyte beta-2 microglobulin because this analyte is not available on

this system.

(4908) Platelet Count:

The test systems Abbott Cell-Dyn 400 (04230), Abbott Cell-Dyn 500

(04231), and Abbott Cell-Dyn 700 (04233) have been deleted from the

analyte platelet count because these instruments do not analyze this

analyte.

Analyte Nomenclature and Use

We will use the term ``direct bilirubin'' to refer to the analyte

``conjugated bilirubin''.

Due to the different nomenclature systems associated with many flow

cytometer analytes, we will list each analyte by the terminology

furnished by the manufacturer.

Thyroid Peroxidase Autoantibodies (TPO) and Anti-Thyroid Microsomal

Antibodies (AMA) refer to the same analyte. To avoid confusion, we will

list the analyte nomenclature used by the manufacturer in the package

insert for the test system being categorized.

For purposes of clarification, the analyte (1033) for Cortisol,

Urine has been modified to read Cortisol, Urine (direct procedure), and

a new analyte (1095) Cortisol, Urine (extraction procedure) has been

established.

Speciality/Subspeciality Changes

In previous publications of the Test Categorization List, analyte/

test systems were assigned to speciality/subspeciality categories based

upon the most recognized area in the clinical laboratory where these

procedures are generally performed. In an effort to coordinate

regulatory responsibilities between the Health Care Financing

Administration (HCFA) and the CDC, we have redefined the speciality/

subspeciality categories for some analytes to conform to HCFA's common

procedure coding system for Medicare payment. Consequently, in this

publication, you will note that the analytes (0476) Acetylcholine/

choline, [[Page 25949]] (0426) Aminoglycosides, (0705) Blood Lead,

(1012) Carboxyhemoglobin, (2541) Histamine, and (3712) Lithium have

been moved to Toxicology; the analytes (0424) Alpha Fetoprotein--tumor

marker, (1051) C1-Esterase Inhibitor (C1INH), and (4927) Platelet

Antibody--detection have been moved to General Immunology; the analytes

(1049) Cancer Antigen 125 (CA125), (1013) Carcinoembryonic Antigen

(CEA), (1015) Ceruloplasmin, (2511) Haptoglobin, (3717) Lysozyme,

(4911) Prealbumin, (4919) Prostatic Specific Antigen (PSA), (4920)

Protein Fractions, (6114) Transferrin, and (6129) Trypsin have been

moved to General Chemistry; the analyte (4021) Malarial Parasite has

been moved to Parasitology. Also, a number of analytes that were

previously listed under the speciality of General Chemistry or the

subspeciality of Toxicology are now listed under the subspeciality of

Endocrinology. These analytes, with their respective codes, are:

(0106) 17 Ketosteroid

(0102) 17 OH Progesterone

(0103) 17 OH Progesterone, Neonatal

(0101) 5-Hydroxyindolacetic Acid (5-HIAA)

(0472) Adenosine Monophosphate, Cyclic (cAMP)

(0458) Adrenocorticotropic Hormone (ACTH)

(0459) Aldosterone

(0466) Androstanediol Glucuronide (3 alpha-diol G)

(0460) Androstenedione

(0479) Angiotensin I

(1040) Calcitonin

(1056) Catecholamines, Plasma

(1055) Catecholamines, Urine

(1032) Cortisol

(1033) Cortisol, Urine (direct procedure)

(1095) Cortisol, Urine (extraction procedure)

(1043) Cyclic AMP

(1309) Dehydroepiandrosterone (DHEA)

(1310) Dehydroepiandrosterone Sulfate (DHEA-SO4

(1611) Erythropoietin

(1605) Estradiol

(1606) Estriol-Total

(1607) Estriol-unconjugated

(1908) Follicle Stimulating Hormone (FSH)

(2205) Gastrin

(2206) Glucagon

(2502) HCG, Beta, Serum, Quantitative

(2501) HCG, Serum, Qualitative

(2555) HCG, Total, Serum, Quantitative

(2503) HCG, Urine, Qualitative (non-waived procedures)

(2534) HCG, Urine, Quantitative

(2543) HCG, Whole Blood, Qualitative

(2545) Homovanillic Acid (HVA)

(2547) Human Growth Hormone

(2533) Human Placental Lactogen (hPL)

(2812) Insulin

(2818) Insulin-like Growth Factor-1 (IGF-1)

(3713) Luteinizing Hormone (LH)

(4025) Metanephrines, Urine

(4934) Parathyroid Hormone--C-Terminal

(4924) Parathyroid Hormone--Intact

(4925) Parathyroid Hormone--Mid-molecule (PTH-M)

(4914) Progesterone

(4915) Prolactin

(5515) Renin

(5820) Serotonin

(5819) Sex Hormone Binding Globulin

(6102) Testosterone

(6122) Testosterone, Free

(6110) Thyroid Binding Globulin (TBG)

(6106) Thyroid Stimulating Hormone (TSH)

(6107) Thyroid Stimulating Hormone (TSH) (Neonatal)

(6108) Thyroid Stimulating Hormone--high sens. (TSH-HS)

(6109) Thyroxine (T4)

(6123) Thyroxine (T4), Neonatal

(6110) Thyroxine Binding Globulin (TBG)

(6111) Thyroxine, Free (FT4)

(6119) Triiodothyronine (T3)

(6120) Triiodothyronine Uptake (T3U) (TU)

(6121) Triiodothyronine, Free (FT3)

(6710) Vanillylmandelic Acid (VMA)

Dated: May 2, 1995.

Philip R. Lee,

Assistant Secretary for Health.

List of Previously Unpublished Categorizations

The test categorization scoring scheme was based on an assessment

of the complexity of the operation of the test procedure and not on an

evaluation of data documenting the procedure's performance over time.

Therefore, the categorization of a test system, assay or examination as

moderate or high complexity should not be interpreted as an indication

of the acceptability or unacceptability of the accuracy, precision or

overall performance of the procedure.

COMPLEXITY: MODERATE

SPECIALITY/SUBSPECIALITY: Bacteriology

ANALYTE: Aerobic &/or Anaerobic Organisms-unlimited sources (0412)

TEST SYSTEM, ASSAY OR EXAMINATION:

Difco ESP Blood Culturing System (13275)

Growth/No Growth of Bacteria on Solid Culture Media (22167)

Organon Teknika Bact/Alert 120 (46148)

ANALYTE: Aerobic Organisms from urine specimens only (0468)

TEST SYSTEM, ASSAY OR EXAMINATION:

Difco EZ Streak Urine Culture Device (colony court only) (13311)

Savyon Diagnostic DIASLIDE (colony count only) (58290)

Traditional Blood Agar Streak Plate (colony count only) (61131)

Vitek Systems Bac-T-Screen 2000 (bacteriuria) (67039)

Vitek Systems Bac-T-Screen 402A (bacteriuria) (67049)

Vitek Systems Bac-T-Screen 500 (bacteriuria) (67050)

ANALYTE: Chlamydia (1016)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott TestPack Chlamydia (direct antigen/visual) (04518)

Wampole Clearview Chlamydia (direct antigen/visual) (70140)

ANALYTE: Clostridium difficile (1022)

TEST SYSTEM, ASSAY OR EXAMINATION:

Meridian Diagnostics ImmunoCard C. difficile (dir.Ag/visual)

(40165)

ANALYTE: Gardnerella vaginalis (2212)

TEST SYSTEM, ASSAY OR EXAMINATION:

MicroProbe Affirm VP Microbial Identification Test Kit (40135)

MicroProbe Affirm VPIII Microbial Identification Test (40163)

ANALYTE: Helicobacter pylori (2512)

TEST SYSTEM, ASSAY OR EXAMINATION:

Serim PyloriTek Test Kit (58338)

ANALYTE: Streptococcus, group A (5810)

TEST SYSTEM, ASSAY OR EXAMINATION:

Becton Dickinson Precise STREP A (direct antigen/visual) (07426)

Syntron QuikPac Strep A (EIA) Test (direct antigen/visual)

(58291)

Wampole Clearview Strep A (direct antigen/visual) (70141)

ANALYTE: Streptococcus, group A (from throat only) (5828)

TEST SYSTEM, ASSAY OR EXAMINATION:

Medix Biotech BESTest Strep A (40193)

Quidel QuickVue One-Step Strep A Test (52024)

ANALYTE: Streptococcus, group B (5811)

TEST SYSTEM, ASSAY OR EXAMINATION:

BioStar Strep B OIA (direct antigen/visual) (07540)

ANALYTE: Vibrio cholerae (6716)

TEST SYSTEM, ASSAY OR EXAMINATION:

New Horizons CholeraScreen (43084)

SPECIALITY/SUBSPECIALITY: Endocrinology

ANALYTE: Cortisol (1032)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning ACS 180 (10046)

Cirrus Diagnostics Immulite (10159)

Sanofi Pasteur Access Immunoassay System (58257)

Schiapparelli Biosystems ACE Clinical Chemistry System

(58288) [[Page 25950]]

Vitek Systems Vidas (67038)

ANALYTE: Cortisol, Urine (direct procedure) (1033)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott TDX (04071)

Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Dehydroepiandrosterone (DHEA) (1309)

TEST SYSTEM, ASSAY OR EXAMINATION:

Serono Baker SR 1 (58090)

ANALYTE: Dehydroepiandrosterone Sulfate (DHEA-SO4) (1310)

TEST SYSTEM, ASSAY OR EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Estradiol (1605)

TEST SYSTEM, ASSAY OR EXAMINATION:

Baxter Stratus II (07051)

Baxter Stratus IIntellect (07376)

Boehringer Mannheim ES 300 AL (07524)

Ciba Corning ACS 180 (10046)

Cirrus Diagnostics Immulite (10159)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

TOSOH A1A-1200 (61040)

TOSOH A1A-600 (61039)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Estriol-unconjugated (1607)

TEST SYSTEM, ASSAY OR EXAMINATION:

Wallac Oy AutoDELFIA (70167)

ANALYTE: Follicle Stimulating Hormone (FSH) (1908)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Du Pont ACA III with aca plus Immunoassay System (13253)

Du Pont ACA IV with aca plus Immunoassay System (13254)

Du Pont ACA SX with aca plus Immunoassay System (13313)

Du Pont ACA Star with aca plus Immunoassay System (13358)

Du Pont ACA V with aca plus Immunoassay System (13255)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: HCG, Beta, Serum, Quantitative (2502)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Du Pont ACA Star with aca plus Immunoassay System (13358)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Sanofi Pasteur Access Immunoassay System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: HCG, Serum, Qualitative (2501)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott TestPack PLUS hCG COMBO (04375)

Access Medical Systems ImmunoCLONE hCG Test (04377)

Applied Biotech SureStep Combo hCG (04528)

Disease Detection International Pro-Step PT hCG (13271)

Disease Detection International Pro-Step hCG (13270)

King's Bay Prelude hCG Combo Kit (34062)

Mainline Technology MAINLINE Confirms hCG (40190)

Princeton BioMeditech BioSign hCG One Step Pregnancy Test

(49080)

Quidel QuickVue One-Step hCG Combo Test (52022)

SA Scientific SAS Serum/Urine hCG (58283)

Stanbio QuPid Plus hCG Pregnancy Test (58326)

Syntron Bioresearch QuikPac II hCG Combo Kit (58353)

TECH-CO Visual HCG Pregnancy Test (61099)

True Medix Beta Spec hCG (61139)

Unipath Clearview HCG DUO (64031)

ANALYTE: HCG, Total, Serum, Quantitative (2555)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ciba Corning ACS 180 (10046)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

ANALYTE: HCG, Urine, Qualitative (non-waived procedures) (2503)

TEST SYSTEM, ASSAY OR EXAMINATION:

Applied Biotech Pregslide HCG Test (04498)

Diagnostic Specialties Pregna-Cert (13276)

J & S Medical Accutex B-HCG Latex Test (31011)

SA Scientific SAS Direct Monoclonal hCG (58319)

SA Scientific SAS Monoclonal HCG-Slide (58281)

ANALYTE: Human Growth Hormone (GH) (2547)

TEST SYSTEM, ASSAY OR EXAMINATION:

Wallac Oy AutoDELFIA (70167)

ANALYTE: Insulin (2812)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

ANALYTE: Luteinizing Hormone (LH) (3713)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Du Pont ACA III with aca plus Immunoassay System (13253)

Du Pont ACA IV with aca plus Immunoassay System (13254)

Du Pont ACA Star with aca plus Immunoassay System (13358)

Du Pont ACA V with aca plus Immunoassay System (13255)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Parathyroid Hormone--Intact (4924)

TEST SYSTEM, ASSAY OR EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Progesterone (4914)

TEST SYSTEM, ASSAY OR EXAMINATION:

Baxter Stratus II (07051)

Baxter Stratus IIntellect (07376)

Boehringer Mannheim ES 300 AL (07524)

Ciba Corning ACS 180 (10046)

Cirrus Diagnostics Immulite (10159)

TOSOH A1A-1200 (61040)

TOSOH A1A-600 (61039)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Prolactin (4915)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA III with aca plus Immunoassay System (13253)

Du Pont ACA IV with aca plus Immunoassay System (13254)

Du Pont ACA SX with aca Immunoassay System (13313)

Du Pont ACA Star with aca plus Immunoassay System (13358)

Du Pont ACA V with aca plus Immunoassay System (13255)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay System (58257)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Sex Hormone Binding Globulin (5819)

TEST SYSTEM, ASSAY OR EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Testosterone (6102)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ciba Corning ACS 180 (10046)

ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)

TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25951]]

Bio-Rad RADIAS System (07493)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA Star with aca plus Immunoassay System (13358)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Roche Cobas Core (55119)

Vitek Systems Vidas (67038)

Wallac OY AutoDELFIA (70167)

ANALYTE: Thyroid Stimulating Hormone (TSH) (Neonatal) (6107)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad RADIAS System (07493)

ANALYTE: Thyroid Stimulating Hormone--high sens. (TSH-HS) (6108)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad RADIAS System (07493)

Boehringer Mannheim ES 300 AL (07524)

Sanofi Pasteur Access Immunoassay System (58257)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Becton Dickinson IQ Immunochemical System (07429)

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay System (58257)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Thyroxine Binding Globulin (TBG) (6110)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

Technicon Immuno 1 System (61042)

ANALYTE: Thyroxine Uptake (T4U) (TU) (6139)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont Dimension XL (13355)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

ANALYTE: Thyroxine, Free (FT4) (6111)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Bio-Rad RADIAS System (07493)

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS (49001)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay System (58257)

Technicon Immuno 1 System (61042)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (60167)

ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim ES 300 AL (07524)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay System (58257)

TOSOH A1A-120DX (61154)

Vitek Systems Vidas (67038)

Wallac Oy AutoDELFIA (70167)

ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott TDX FLx (04072)

Beckman Synchron CX 5 CE (07491)

Becton Dickinson IQ Immunochemical System (07429)

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Organon Teknika AuraFlex (46152)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Sanofi Pasteur Access Immunoassay System (58257)

SPECIALITY/SUBSPECIALITY: General Chemistry

ANALYTE: Acid Phosphatase (0407)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 500 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Albumin (0414)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34504)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Albumin, Urinary (0516)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA II (13172)

Du Pont ACA III (13173)

Du Pont ACA IV (13083)

Du Pont ACA Star (13357)

Du Pont ACA V (13084)

ANALYTE: Aldolase (0415)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Alkaline Phosphatase (ALP) (0416)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056) [[Page 25952]]

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Alpha-Hydroxybutyrate Dehydrogenase (HBDH) (0419)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Du Pont ACA Star (13357)

ANALYTE: Ammonia, Plasma/Serum (0427)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Abbott VP (04082)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

ANALYTE: Amylase (0429)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Amylase, pancreatic isoenzymes (p-Amylase) (0500)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 4 (07071)

Beckman Synchron CX 5 (07072)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 705 (07162)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

ANALYTE: Apolipoprotein A1 (0462)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Instrumentation Laboratory IL Monarch 1000 (28082)

Instrumentation Laboratory IL Monarch 2000 (28231)

Instrumentation Laboratory IL Monarch Plus (28083)

Olympus AU 5041 (46145)

ANALYTE: Apolipoprotein B (0457)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Olympus AU 5041 (46145)

ANALYTE: Aspartate Aminotransferase (AST) (SGOT) (0405)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5131 (46088)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Bilirubin, Direct (0704)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCS (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

LSI ASCA Chemistry System (37069)

Olmpus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Bilirubin, Neonatal (0705)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Du Pont ACA Star (13357)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem DT II (34057)

ANALYTE: Bilirubin, Total (0706)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Techicon OPERA Clinical Chemistry System (61161)

ANALYTE: Blood Gases with pH (0708)

TEST SYSTEM, ASSAY OR EXAMINATION:

AVL Compact 1 (04552)

AVL Compact 2 (04555)

AVL OPTI 1 (04572)

Ciba Corning 248 (10260)

Ciba Corning 840 (10250)

Ciba Corning 845 (10296)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical DMI Blood Gas Analyzer (13274)

Diametrics Medical IRMA Blood Analysis System (13362)

I-STAT i-STAT 200 System (28344)

I-STAT i-STAT Portable Clinical Analyzer (28186)

Instrumentation Laboratory Blood Gas 1610 (28335)

Instrumentation Laboratory Blood Gas 1620 (28336)

Instrumentation Laboratory Blood Gas 1630 (28337)

Instumentation Laboratory Blood Gas 1640 (28338)

Instrumentation Laboratory Blood Gas 1650

(28339) [[Page 25953]]

Instrumentation Laboratory IL 1430 BGElectrolyte (28343)

Nova Stat profile 7 (43035)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer (43101)

PPG Industries StatPal II Blood Gas Analysis System (49092)

Radiometer ABL 5 (55136)

Radiometer ABL 620 (55137)

ANALYTE: Blood pH (no blood gases) (07221)

TEST SYSTEM, ASSAY OR EXAMINATION:

AVL 9110 pH Analyzer (04523)

AVL 988-4 (04556)

Ionetics Model 400/450 Electrolyte Analyzer (28324)

Medica EasyLyte Calcium Analyzer (40197)

ANALYTE: Calcium, Ionized (1004)

TEST SYSTEM, ASSAY OR EXAMINATION:

AVL 988-4 (04556)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical IRMA Blood Analysis System (13362)

I-STAT i-STAT 200 System (28344)

I-STAT i-STAT Portable Clinical Analyzer (28186)

Instrumentation Laboratory Blood Gas 1640 (28338)

Ionetics Model 400/450 Electrolyte Analyzer (28324)

Medica EasyLyte Calcium Analyzer (40197)

Nova Stat Profile 9 (43086)

Nova Stat Profile Ultra 11P Analyzer (43101)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

ANALYTE: Calcium, Total (1005)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron AS-X (07069)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 10 (with CRT) (43061)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Carbon Dioxide, Total (CO2) (1003)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Carcinoembryonic Antigen (CEA) (1013)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim ES 300 (07160)

TOSOH A1A-600 (61039)

ANALYTE: Cerebrospinal Fluid (CSF) Protein (1014)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 4 (07071)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 (07072)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

Du Pont ACA Star (13357)

Du Pont Dimension (13086)

Du Pont Dimension AR (13087)

Du Pont Dimension ES (13215)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

ANALYTE: Ceruloplasmin (1015)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Chloride (1018)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

I-STAT i-STAT 200 System (28344)

Instrumentation Laboratory Blood Gas 1650 (28339)

Instrumentation Laboratory IL 1430 BGElectrolyte (28343)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Instrumentation Laboratory ILyte Na, K, C1 System (28320)

Ionetics Model 400/450 Electrolyte Analyzer (28324)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 10 (with CRT) (43061)

Nova 16 (43103)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Chloride, Sweat (Cystic Fibrosis Sweat Test) (1019)

TEST SYSTEM, ASSAY OR EXAMINATION:

Scandipharm CF Indicator (9800) (58240)

ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

StatChem StatTest Sysem (58269)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Cholinesterase (1021)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546) [[Page 25954]]

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Technicon Chem 1 (61003)

Technicon Chem 1 Plus (61036)

ANALYTE: Creatine Kinase (CK) (1034)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont ACA Star with aca plus Immunoassay System (13358)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II 34057)

LSI ASCA Chemistry System (37069)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Princeton BioMeditech AccuSign MI CK-MB/Myoglobin (49143)

Princeton BioMeditech CarePoint MI CK-MB/Myoglobin (49141)

Princeton BioMeditech LifeSign MI CK-MB/Myoglobin (49140)

Princeton BioMeditech VitalSign MI CK-MB/Myoglobin (49142)

Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Creatinine (1035)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Bio-Rad RADIAS System (07493)

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA III with aca plus Immunoassay System (13253)

Du Pont ACA IV with aca plus Immunoassay System (13254)

Du Pont ACA Star with aca plus Immunoassay System (13358)

Du Pont ACA V with aca plus Immunoassay System (13255)

Olympus Reply (46089)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Roche Cobas Core (55119)

Roche Cobas FARA (55040)

Roche Cobas FARA II (55041)

Roche Cobas Mira Plus (55096)

Sanofi Pasteur Access Immunoassay System (58257)

Seradyn LPIA-100 (58294)

Syva Vista Immunoassay System (58221)

Vitek Systems Vidas (67038)

ANALYTE: Folate (Folic acid) (1907)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad RADIAS System (07493)

Boehringer Mannheim Hitachi 911 (07377)

Cirrus Diagnostics Immulite (10159)

Roche Cobas Mira Plus (55096)

Sanofi Pasteur Access Immunoassay System (58257)

Syva Vista Immunoassay System (58221)

ANALYTE: Folate, Red Blood Cell (RBC Folate) (1930)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ciba Corning ACS 180 (10046)

Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Fructosamine (1914)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim Hitachi 736 (07164)

Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Glucose (2203)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Cholestech L.D.X. (10170)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

I-STAT i-STAT 200 System (28344)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer (43101)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

StatChem StatTest System (58269) [[Page 25955]]

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

Yellow Springs YSI Model 23A Blood Glucose Analyzer (76006)

ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott IMX (04056)

Beckman Synchron CX 4 (07071)

Beckman Synchron CX 5 (07072)

Beckman Synchron CX 7 (07073)

Bio-Rad RADIAS System (07493)

Bio-Rad Variant (07498)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Roche Cobas FARA (55040)

Roche Cobas Mira (55044)

ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum (DMA One Shots) (04598)

Abbott Spectrum (MHS SPINPRO) (04563)

Abbott Spectrum (T-Am. Singles) (04588)

Abbott Spectrum CCX (DMA One Shots) (04599)

Abbott Spectrum CCX (T-Am. Singles) (04587)

Abbott Spectrum EPX (DMA One Shots) (04600)

Abbott Spectrum EPX (MHS SPINPRO) (04564)

Abbott Spectrum EPX (T-Am. Singles) (04565)

Abbott Spectrum Series II (DMA One Shots) (04601)

Abbott Spectrum Series II (MHS SPINPRO) (04566)

Abbott Spectrum Series II (T-Am. Singles) (04589)

Abbott Spectrum Series II CCX (DMA One Shots) (04602)

Abbott Spectrum Series II CCX (MHS SPINPRO) (04567)

Abbott Spectrum Series II CCX (T-Am. Singles) (04590)

Abbott TDX (04071)

Abbott TDX (MHS SPINPRO) (04568)

Abbott TDX FLx (04072)

Abbott TDX FLx (MHS SPINPRO) (04569)

Abbott VP (DMA One Shots) (04603)

Abbott VP (MHS SPINPRO) (04570)

Abbott Vision, Non Whole Blood HDL Procedure (04451)

Abbott Vision, Non Whole Blood HDL Procedure (MHS SPINPRO)

(04571)

Ames Seralyzer (DMA One Shots) (04604)

Ames Seralyzer III (DMA One Shots) (04605)

Baxter Paramax (DMA One Shots) (07618)

Baxter Paramax (MHS SPINPRO) (07566)

Baxter Paramax 720 ZX (DMA One Shots) (07619)

Baxter Paramax 720 ZX (MHS SPINPRO) (07567)

Beckman Astra 8 (MHS SPINPRO) (07568)

Beckman Astra 8e (MHS SPINPRO) (07569)

Beckman Astra Ideal (MHS SPINPRO) (07570)

Beckman Synchron AS-X (MHS SPINPRO) (07571)

Beckman Synchron AS-Xe (MHS SPINPRO) (07572)

Beckman Synchron AS Xi (MHS SPINPRO) (07573)

Beckman Synchron CX 4 (DMA One Shots) (07620)

Beckman Synchron CX 4 (MHS SPINPRO) (07574)

Beckman Synchron CX 4 CE (DMA One Shots) (07621)

Beckman Synchron CX 4 CE (MHS SPINPRO) (07575)

Beckman Synchron CX 5 (DMA One Shots) (07622)

Beckman Synchron CX 5 (MHS SPINPRO) (07576)

Beckman Synchron CX 5 (T-Am. Singles) (07577)

Beckman Synchron CX 5 CE (DMA One Shots) (07623)

Beckman Synchron CX 7 (DMA One Shots) (07624)

Beckman Synchron CX 7 (MHS SPINPRO) (07578)

Beckman Synchron CX 7 (T-Am. Singles) (07579)

Bio-Chem Laboratory Systems ATAC 2000/2100 (DMA One Shots)

(07634)

Bio-Chem Laboratory Systems ATAC 6000 (DMA One Shots) (07626)

Bio-Chem Laboratory Systems ATAC 6000 (T-Am. Singles) (07596)

BioAutoMed ASCA (07192)

BioAutoMed ASCA (DMA One Shots) (07625)

Boehringer Mannheim Hitachi 704 (DMA One Shots) (07627)

Boehringer Mannheim Hitachi 704 (MHS SPINPRO) (07580)

Boehringer Mannheim Hitachi 704 (T-Am. Singles) (07590)

Boehringer Mannheim Hitachi 705 (DMA One Shots) (07628)

Boehringer Mannheim Hitachi 705 (MHS SPINPRO) (07581)

Boehringer Mannheim Hitachi 705 (T-Am. Singles) (07591)

Boehringer Mannheim Hitachi 717 (DMA One Shots) (07629)

Boehringer Mannheim Hitachi 717 (MHS SPINPRO) (07582)

Boehringer Mannheim Hitachi 717 (T-Am. Singles) (07592)

Boehringer Mannheim Hitachi 736 (DMA One Shots) (07630)

Boehringer Mannheim Hitachi 736 (MHS SPINPRO) (07583)

Boehringer Mannheim Hitachi 736 (T-Am. Singles) (07593)

Boehringer Mannheim Hitachi 737 (DMA One Shots) (07631)

Boehringer Mannheim Hitachi 737 (MHS SPINPRO) (07584)

Boehringer Mannheim Hitachi 737 (T-Am. Singles) (07594)

Boehringer Mannheim Hitachi 747 (DMA One Shots) (07632)

Boehringer Mannheim Hitachi 747 (MHS SPINPRO) (07585)

Boehringer Mannheim Hitachi 747 (T-Am. Singles) (07595)

Boehringer Mannheim Hitachi 911 (MHS SPINPRO) (07586)

Ciba Corning 550 Express (DMA One Shots) (10291)

Ciba Corning 550 Express (MHS SPINPRO) (10274)

Ciba Corning 550 Express (T-Am. Singles) (10273)

Ciba Corning 570 Alliance (MHS SPINPRO) (10275)

Ciba Corning 580 Alliance (MHS SPINPRO) (10276)

Coulter Dacos (DMA One Shots) (10292)

Coulter Dacos (T-Am. Singles) (10277)

Coulter Optichem (T-Am. Singles) (10278)

Coulter Optichem 100 (DMA One Shots) (10293)

Du Pont ACA (DMA One Shots) (13365)

Du Pont ACA (MHS SPINPRO) (13346)

Du Pont ACA II (DMA One Shots) (13366)

Du Pont ACA II (MHS SPINPRO) (13347)

Du Pont ACA III (DMA One Shots) (13367)

Du Pont ACA III (MHS SPINPRO) (13348)

Du Pont ACA IV (DMA One Shots) (13368)

Du Pont ACA IV (MHS SPINPRO) (13349)

Du Pont ACA V (DMA One Shots) (13369)

Du Pont ACA V ((MHS SPINPRO) (13350)

Du Pont Analyst (DMA One Shots) (13364)

Du Pont Analyst (MHS SPINPRO) (13351)

Du Pont Dimension (DMA One Shots) (13370)

Du Pont Dimension (MHS SPINPRO) (13352)

Du Pont Dimension AR (DMA One Shots) (13371)

Du Pont Dimension AR (MHS SPINPRO) (13353)

Du Pont Dimension ES (DMA One Shots) (13372)

Du Pont Dimension ES (MHS SPINPRO) (13354)

EM Diagnostic Systems EPOS (DMA One Shots) (16099)

EM Diagnostic Systems EPOS (MHS SPINPRO) (16094)

Electronucleonics Gem-Profiler (DMA One Shots) (16095)

Electronucleonics Gemini (DMA One Shots) (16096)

Electronucleonics Gemstar (DMA One Shots) (16097)

Electronucleonics Gemstar (T-Am. Singles) (16093)

Electronucleonics Gemstar II (DMA One Shots) (16098)

Instrumentation Laboratory IL Monarch (T-Am. Singles) (28361)

Instrumentation Laboratory IL Monarch 1000 (DMA One Shots)

(28380)

Instrumentation Laboratory IL Monarch 1000 (T-Am. Singles)

(28362)

Instrumentation Laboratory IL Monarch 2000 (DMA One Shots)

(28381)

Instrumentation Laboratory IL Monarch 2000 (T-Am. Singles)

(28363)

Instrumentation Laboratory IL Monarch Plus (DMA One Shots)

(28382)

Instrumentation Laboratory IL Monarch Plus (T-Am. Singles)

(28364)

Kodak Ektachem 250 (DMA One Shots) (34076)

Kodak Ektachem 250 (MHS SPINPRO) (34063)

Kodak Ektachem 400 (DMA One Shots) (34077)

Kodak Ektachem 400 (MHS SPINPRO) (34064)

Kodak Ektachem 500 (DMA One Shots) (34078)

Kodak Ektachem 500 (MHS SPINPRO) (34065)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 550 XRC Analyzer (DMA One Shots)

(34079) [[Page 25956]]

Kodak Ektachem 700 (DMA One Shots) (34080)

Kodak Ektachem 700 (MHS SPINPRO) (34066)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 700 Analyzer C Series (DMA One Shots) (34081)

Kodak Ektachem 700 P (DMA One Shots) (34082)

Kodak Ektachem 700 P (MHS SPINPRO) (34067)

Kodak Ektachem 700 XR (DMA One Shots) (34083)

Kodak Ektachem 700 XR (MHS SPINPRO) (34068)

Kodak Ektachem 750 XRC (DMA One Shots) (34084)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT 60 (DMA One Shots) (34085)

Kodak Ektachem DT 60 (MHS SPINPRO) (34069)

Kodak Ektachem DT II (34057)

Kodak Ektachem DT II (DMA One Shots) (34086)

LSI ASCA Chemistry System (37069)

LSI ASCA Chemistry System (DMA One Shots) (37096)

LSI ASCA Chemistry System (T-Am. Singles) (37095)

Olympus AU 5000 (DMA One Shots) (46173)

Olympus AU 5021 (DMA One Shots) (46174)

Olympus AU 5031 (DMA One Shots) (46175)

Olympus AU 5041 (DMA One Shots) (46176)

Olympus AU 5061 (DMA One Shots) (46177)

Olympus AU 5121 (DMA One Shots) (46178)

Olympus AU 5131 (DMA One Shots) (46179)

Olympus AU 5200 (DMA One Shots) (46180)

Olympus AU 5211 (DMA One Shots) (46181)

Olympus AU 5221 (DMA One Shots) (46182)

Olympus AU 5223 (DMA One Shots) (46183)

Olympus AU 5231 (DMA One Shots) (46184)

Olympus AU 800 (DMA One Shots) (46185)

Olympus AU 5000 (MHS SPINPRO) (46161)

Olympus AU 5000 (T-Am. Singles) (46166)

Olympus Demand (DMA One Shots) (46186)

Olympus Demand (MHS SPINPRO) (46162)

Olympus Demand (T-Am. Singles) (46164)

Olympus Reply (DMA One Shots) (46187)

Olympus Reply (MHS SPINPRO) (46163)

Olympus Reply (T-Am. Singles) (46165)

Olympus Reply/AU560 (DMA One Shots) (46188)

PrismaSystems PROCHEM (49105)

Roche Cobas Bio (DMA One Shots) (55152)

Roche Cobas Bio (MHS SPINPRO) (55140)

Roche Cobas Bio (T-Am. Singles) (55143)

Roche Cobas FARA (DMA One Shots) (55153)

Roche Cobas FARA II (DMA One Shots) (55154)

Roche Cobas Fara (MHS SPINPRO) (55141)

Roche Cobas Fara (T-Am. Singles) (55144)

Roche Cobas MIRA (DMA One Shots) (55155)

Roche Cobas MIRA Plus (DMA One Shots) (55156)

Roche Cobas MIRA S (DMA One Shots) (55157)

Roche Cobas Mira (MHS SPINPRO) (55142)

Roche Cobas Mira (T-Am. Singles) (55145)

Schiapparelli Biosystems ACE (DMA One Shots) (58357)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon Assist (DMA One Shots) (61181)

Technicon RA 100 (DMA One Shots) (61182)

Technicon RA 1000 (DMA One Shots) (61183)

Technicon RA 1000 (MHS SPINPRO) (61162)

Technicon RA 1000 (T-Am. Singles) (61164)

Technicon RA 2000 (DMA One Shots) (61184)

Technicon RA 500 (DMA One Shots) (61185)

Technicon RA 500 (T-Am. Singles) (61163)

Technicon RA XT (DMA One Shots) (61186)

Technicon RA XT (T-Am. Singles) (61165)

ANALYTE: Haptoglobin (2511)

TEST SYSTEM, ASSAY OR EXAMINATION

Behring Nephelometer II (07563)

ANALYTE: Hemoglobin S (2536)

TEST SYSTEM, ASSAY OR EXAMINATION:

Histo-Med Sickle Cell Reagent Set (25164)

ANALYTE: Iron (2814)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT SC Module (34017)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Lactate Dehydrogenase (LDH) (3701)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Lactate Dehydrogenase Heart Fraction (LDH-1) (3702)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

ANALYTE: Lactate Dehydrogenase Liver Fraction (LLDH) 3703)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

ANALYTE: Lactic Acid (Lactate) (3704)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer (43101)

Technicon OPERA Clinical Chemistry System (61161)

Yellow Springs YSI Model 23L Blood Lactoat Analyzer (76007)

ANALYTE: Lactoferrin (3727)

TEST SYSTEM, ASSAY OR EXAMINATION:

TechLab LEUKO-TEST (61133)

Touch Scientific LactoCard Tear Lactoferrin Immunoassay

(61110) [[Page 25957]]

Touch Scientific Lactoferrin MicroAssay System (61137)

ANALYTE: Leucine Aminopeptidase (LAP) (3709)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

ANALYTE: Lipase (3711)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT 60 (34016)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

ANALYTE: Magnesium (4002)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 8 (43022)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon Chem 1 Plus (61036)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Magnesium, Ionized (4018)

TEST SYSTEM, ASSAY OR EXAMINATION:

AVL 988-4 (04556)

Nova Stat Profile Ultra 11P Analyzer (43101)

ANALYTE: Methemoglobin (4032)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

ANALYTE: Microalbumin (4019)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim Hitachi 747 (07166)

Boehringer Mannheim Hitachi 911 (07377)

ANALYTE: Microprotein, CSF (4026)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 914 (07546)

Olympus AU 5041 (46145)

Olympus AU 800 (46110)

ANALYTE: Microprotein, Urine (4027)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Beckman Synchron CX 7 (07073)

Boehringer Mannheim Hitachi 914 (07546)

Olympus AU 5041 (46145)

Olympus AU 800 (46110)

ANALYTE: Myoglobin (4023)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Princeton BioMeditech AccuSign MI CK-MB/Myoglobin (49143)

Princeton BioMeditech CarePoint MI CK-MB/Myoglobin (49141)

Princeton BioMeditech LifeSign MI CK-MB/Myoglobin (49140)

Princeton BioMeditech LifeSign MI Myoglobin (49122)

Princeton BioMeditech VitalSign MI CK-MB/Myoglobin (49142)

ANALYTE: Osmolality, Serum (4602)

TEST SYSTEM, ASSAY OR EXAMINATION:

Advanced Instruments Model 3D3 Osmometer (04520)

ANALYTE: Osmolality, Urine (4603)

TEST SYSTEM, ASSAY OR EXAMINATION:

Advanced Instruments Model 3D3 Osmometer (04520)

ANALYTE: Oxyhemoglobin/Oxygen Saturation (4604)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

Radiometer ABL 620 (55137)

ANALYTE: Phosphorus (4906)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont ACA Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Potassium (4910)

TEST SYSTEM, ASSAY OR EXAMINATION:

AVL 988-4 (04556)

American Monitor Parallel (04144)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical IRMA Blood Analysis System (13362)

Du Pont Dimension XL (13355)

I-STAT i-STAT 200 System (28344)

Instrumentation Laboratory Blood Gas 1630 (28337)

Instrumentation Laboratory Blood Gas 1640 (28338)

Instrumentation Laboratory Blood Gas 1650 (28339)

Instrumentation Laboratory IL 1430 BGElectrolyte (28343)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Instrumentation Laboratory ILye Na, K, Cl System (28320)

Instrumentation Laboratory ILye Na, K, Li System (28319)

Ionetics Model 400/450 Electrolyte Analyzer (28324)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Medica EasyLyte Calcium Analyzer (40197)

Nova 10 (with CRT) (43061)

Nova 16 (43103)

Nova 8 (43022)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer (43101)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PDX Stat K Rapid Potassium Test System (49102)

PrismaSystems PROCHEM (49105)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

StatChem StatTest Sysem (58269)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Prealbumin (4911)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

'ANALYTE: Prostatic Acid Phosphatase (PAP) (4918) [[Page 25958]]

TEST SYSTEM, ASSAY OR EXAMINATION:

Cirrus Diagnostics Immulite (10159)

ANALYTE: Prostatic Specific Antigen (PSA) (4919)

TEST SYSTEM, ASSAY OR EXAMINATION:

TOSOH A1A-1200 (61040)

ANALYTE: Protein, Total (4921)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abaxis EPOC 2000 (04547)

Abott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Protein, Total (urine) (4972)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

Du Pont Dimension (13086)

Du Pont Dimension AR (13087)

Du Pont Dimension ES (13215)

Du Pont Dimension XL (13355)

ANALYTE: Pseudocholinesterase (4923)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

ANALYTE: Reduced Hemoglobin (5523)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

ANALYTE: Retinol binding protein (5507)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Sodium (5805)

TEST SYSTEM, ASSAY OR EXAMINATION:

AVL 988-4 (04556)

Abbott Vision (04083)

American Monitor Parallel (04144)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning 850 (10251)

Ciba Corning 855 (10297)

Ciba Corning 860 (10269)

Ciba Corning 865 (10298)

Diametrics Medical IRMA Blood Analysis System (13362)

Du Pont Dimension XL (13355)

I-STAT i-STAT 200 System (28344)

Instrumentation Laboratory Blood Gas 1630 (28337)

Instrumentation Laboratory Blood Gas 1640 (28338)

Instrumentation Laboratory Blood Gas 1650 (28339)

Instrumentation Laboratory IL 1430 BGElectrolyte (28343)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Instrumentation Laboratory ILyte Na, K, Cl System (28320)

Instrumentation Laboratory ILyte Na, K, Li System (28319)

Ionetics Model 400/450 Electrolyte Analyzer (28324)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

Medica EasyLyte Calcium Analyzer (40197)

Nova 10 (with CRT) (43061)

Nova 16 (43103)

Nova 8 (43022)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer (43101)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

Radiometer ABL 620 (55137)

Radiometer EML 100 (55134)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Total Solids (Protein) (6131)

TEST SYSTEM, ASSAY OR EXAMINATION:

ATAGO A300CL Clinincal Refractometer (04575)

ATAGO N Serum Protein Refractometer (04574)

ATAGO SP-D Digital Serum Protein Refractometer (04579)

ATAGO T-2 Clinical Refractometer (04577)

National Instrument Hand Protometer (43085)

ANALYTE: Transferrin (6114)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems Prochem (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Troponin T (Tn T) (6140)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim ES 300 (07160)

ANALYTE: Urea (BUN) (6403)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 3 Delta (07548)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

I-STAT i-STAT 200 System (28344)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Nova 16 (43103)

Nova Stat Profile Plus 10 (43063)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Synermed IR 500 (58322)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Uric Acid (6404)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abaxis EPOC 2000 (04547)

Abbott Spectrum CCX (04515)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355) [[Page 25959]]

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

PrismaSystems PROCHEM (49105)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Vitamin B12 (6707)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad RADIAS System (97493)

Roche Cobas Mira Plus (55096)

Sanofi Pasteur Access Immunoassay System (58257)

Syva Vista Immunoassay System (58221)

Technicon Immuno 1 System (61042)

SPECIALITY/SUBSPECIALITY: General Immunology

ANALYTE: Allergen specific IgE (0417)

TEST SYSTEM, ASSAY OR EXAMINATION:

Cirrus Diagnostic Immulite (10159)

In Vitro Technologies Allergy Profile (28279)

Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Alpha-1 Microglobin (0470)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Array 360 (07052)

Behring Nephelometer II (07563)

ANALYTE: Alpha-1-Acid Glycoprotein (orosomucoid) (0420)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Alpha-1-Antitrypsin (0421)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelomoter II (07563)

ANALYTE: Alpha-2 Macroglobulin (0422)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Alpha-Fetoprotein--Tumor Marker (0424)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

ANALYTE: Anti-Nuclear Antibodies (ANA) (0441)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad Radias System (07493)

J & S Medical Accutex SLE Latex Test (31002)

ANALYTE: Anti-Streptolysin O (ASO) (0452)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

J & S Medical Accutex Antistreptolysin O (ASO) Latex Text

(31006)

ANALYTE: Beta-2 microglobulin (0703)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Array 360 (07052)

Cirrus Diagnostics Immulite (10159)

Du Pont ACA Star (13357)

Du Pont ACA V (13084)

Wallac Oy AutoDELFIA (70167)

ANALYTE: C-Reactive Protein (CRP) (1001)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 747 (07166)

Boehriner Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Immunostics immuno/crp Test (28277)

J & S Medical Accutex C-Reactive Protein (CRP) Latex Text

(31004)

J & S Medical Eye Spot CRP test (31007)

Pulse Scientific C-Reactive Protein (CRP) Test (49075)

Technicon OPERA Clinical Chemistry System (61161

ANALYTE: Complement C3 (1029)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Complement C4 (1030)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Cytomegalovirus Antibodies (1039)

TEST SYSTEM, ASSAY OR EXAMINATION:

PB Diagnostics System OPUS (49001)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Vitek Systems Vidas (67038)

ANALYTE: Helicobacter Pylori Antibodies (2513)

TEST SYSTEM, ASSAY OR EXAMINATION:

Meridian Diagnostics ImmunoCard H. pylori (40195)

SmithKline FlexSure HP Test (58321)

ANALYTE: Hemopexin (2517)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Hepatitis A Virus Antibody (2519)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott IMX (04056)

ANALYTE: Immunoglobulins IgA (2803)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim ES 300 AL (07524)

Cirrus Diagnostics Immulite (10159)

Roche Cobas Core (55119)

Sanofi Pasteur Access Immunoassay System (58257)

Vitek Systems Vidas (67038)

ANALYTE: Immunoglobulins IgG (2806)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Immunoglobulins IgG subclasses (2807)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer (07273)

Behring Nephelometer 100 (07272)

ANALYTE: Immunoglobulins IgM (2808)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Behring Nephelometer II (07563)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Infectious Mononucleosis Antibodies (Mono) (2809)

TEST SYSTEM, ASSAY OR EXAMINATION:

Immunostics immuno/im test (28278)

J & S Medical Accutex Inf. Mono. Red Bld. Cell (IM RBC) Test

(31003)

J & S Medical Accutex Infectious Mononucleosis Latex Test

(31008)

J & S Medical Eye Spot Infectious Mononucleosis (IM) Test

(31013)

Meridian Diagnostics ImmunoCard Mono (40179)

Pacific Biotech Concise Plus Mono (49148)

Princeton BioMeditech BioSign Mono Test (49100)

ANALYTE: Kappa Light Chains (3402)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Lambda Light Chains (3705)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY OR EXAMINATION:

Vitek Systems Vidas (67038)

ANALYTE: Mycoplasma pneumoniae Antibodies (4016)

TEST SYSTEM, ASSAY OR EXAMINATION:

Meridian Diagnostics ImmunoCard Mycoplasma (40196)

Murex Mycoplasma pneumoniae Antibody Detection Kit (40175)

ANALYTE: Rheumatoid Factor (RF) (5508)

TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25960]]

Behring Nephelometer II (07563)

Immunostics immuno/undiluted ra Test (28275)

J & S Medical Accutex Rheumatoid Factor (RF) Latex Test (31005)

J & S Medical Eye Spot Rheumatoid Factor (RF) Test (31012)

Pulse Scientific Rheumatoid Factor (RF) Test (49101)

Trinity Laboratories RHEUMA-LEX System (61116)

ANALYTE: Rickettsia typhi Ab (Typhus Antibodies) (5514)

TEST SYSTEM, ASSAY OR EXAMINATION:

Integrated Diagnostics INDX DIP-S-TICKS R. typhi (28265)

ANALYTE: Rubella Antibodies (5510)

TEST SYSTEM, ASSAY OR EXAMINATION:

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Princeton BioMeditech BioSign Rubella (49121)

Wampole IMPACT Rubella Slide Test (70165)

ANALYTE: Rubeola Antibodies (measles) (5511)

TEST SYSTEM, ASSAY OR EXAMINATION:

Vitek Systems Vidas (67038)

ANALYTE: Toxoplasma gondii Antibodies (6113)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biokit Toxogen (07494)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Vitek Systems Vidas Toxo Competition (TXC) Assay (67080)

ANALTYE: Varicella-Zoster Virus Antibodies (6704)

TEST SYSTEM, ASSAY OR EXAMINATION:

Vitek Systems Vidas (67038)

SPECIALITY/SUBSPECIALITY: Hematology

ANALYTE: Activated Clotting Time (ACT) (0461)

TEST SYSTEM, ASSAY OR EXAMINATION:

HemoTec Automated Coagulation Timer High Range Heparinase

(25184)

HemoTec Automated Coagulation Timer II (25180)

HemoTec Automated Coagulation Timer II High Range Heparinase

(25185)

International Technidyne Hemochron 8000 (28298)

International Technidyne Hemochron Jr. Microcoagulation (28345)

ANALYTE: Activated Partial Thromboplastin Time (APTT) (0409)

TEST SYSTEM, ASSAY OR EXAMINATION:

American Bioproducts STA Analyzer (04594)

Behring Fibrintimer A (07516)

Cardiovascular Diagnostics TAS Analyzer (10257)

Helena Laboratories Cascade M (25156)

HemoTec Automated Coagulation Timer II (25180)

Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)

International Technidyne Factor VI Premier (28296)

International Technidyne Factor VI Premier SingleShot APTT

(28293)

International Technidyne Factor VI Premier Vacu-APTT (28295)

International Technidyne Factor VI SingleShot APTT (28292)

International Technidyne Factor VI Vacu-APTT (28294)

International Technidyne Hemochron 400 Cit. One-Step APTT

(28287)

International Technidyne Hemochron 400 Direct Draw APTT (28282)

International Technidyne Hemochron 401 Cit. One-Step APTT

(28288)

International Technidyne Hemochron 401 Direct Draw APTT (28283)

International Technidyne Hemochron 800 Cit. One-Step APTT

(28289)

International Technidyne Hemochron 800 Direct Draw APTT (28284)

International Technidyne Hemochron 8000 (28298)

International Technidyne Hemochron 8000 Cit. One-Step APTT

(28291)

International Technidyne Hemochron 8000 Direct Draw APTT (28286)

International Technidyne Hemochron 801 Cit. One-Step APTT

(28290)

International Technidyne Hemochron 801 Direct Draw APTT (28285)

International Technidyne Microsample Coagulation Analyzer

(28267)

Medical Laboratory MLA Electra 1600C (40167)

Organon Teknika Multi Channel Discrete Analyzer (MDA-180)

(46144)

TOA Medical Electronics CA-1000 (61132)

TOA Medical Electronics CA-5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: Antithrombin III (ATIII) (0456)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Du Pont ACA Star (13357)

ANALYTE: Body Fluid Microscopic Elements (0716)

TEST SYSTEM, ASSAY OR EXAMINATION:

IRIS IRIScope Body Fld. Cell Count Sys. (RBC/WBC enum. only)

(28333)

ANALYTE: Capillary fragility (1093)

TEST SYSTEM, ASSAY OR EXAMINATION:

Capillary Fragility/Tourniquet Test (10247)

ANALYTE: Fibrin Monomers (1927)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ethanol Gel; Protamine Sulfate (no serial dilutions) (16044)

ANALYTE: Fibrin Split Products (Fibrin Degradation) (1904)

TEST SYSTEM, ASSAY OR EXAMINATION:

Baxter Diagnostic Dimertest Latex Assay (07552)

Baxter Diagnostic FDP Detection Set (07551)

Du Pont ACA Star (13357)

Organon Teknika AuraTek FDP (46153)

Vitek FDP Slidex direct (67084)

ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY OR EXAMINATION:

American Bioproducts STA Analyzer (04594)

Behring Nephelometer II (07563)

Du Pont ACA Star (13357)

Helena Laboratories Cascade M (25156)

Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)

International Technidyne Factor VI (28093)

International Technidyne Factor VI Premier (28296)

International Technidyne Hemochron 400 (28094)

International Technidyne Hemochron 401 (28095)

International Technidyne Hemochron 800 (28096)

International Technidyne Hemochron 8000 (28298)

International Technidyne Hemochron 801 (28097)

Medical Laboratory MLA Electra 1600C (40167)

TOA Medical Electronics CA-1000 (61132)

TOA Medical Electronics CA-5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: Hematocrit (2514)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostic Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Diametrics Medical IRMA Blood Analysis System (13362)

I-STAT i-STAT 200 System (28344)

Infolab I-1600 (28379)

Instrumentation Laboratory BGElectrolytes (28063)

Nova 16 (43103)

Nova Stat Profile 9 (43086)

Nova Stat Profile Plus 10 (43063)

Nova Stat Profile Ultra 11P Analyzer (43101)

Separation Technology STI HemataSTAT Model C70B (58310)

Sysmex K-4500 (58358)

Sysmex K-800 (58307)

Sysmex SE-9000 (58318)

Technalysis CELLEXIS Hematology Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H. 3 RTX System (61104)

Texas International Laboratories H12 (61128)

ANALYTE: Hemoglobin (2515)

TEST SYSTEM, ASSAY OR EXAMINATION:

AVL 995 Hb (04021)

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Artel HbM Hemoglobinometer (04551)

Ciba Corning 280 (10036)

Ciba Corning 288 (10037)

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

Coulter ONYX (10254) [[Page 25961]]

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

I-STAT i-STAT 200 System (28344)

Infolab I-1600 (28379)

Radiometer ABL 1 (55049)

Radiometer ABL 2 (55001)

Radiometer ABL 2 RA (55050)

Radiometer ABL 3 (55002)

Radiometer ABL 3 M (55051)

Radiometer ABL 300 (55004)

Radiometer ABL 4 (55006)

Radiometer ABL 510 (55054)

Radiometer ABL 520 (55055)

Separation Technology STI HemataSTAT Model C70B (58310)

StatChem StatTest System (58269)

Sysmex K-4500 (58358)

Sysmex K-800 (58307)

Sysmex SE-9000 (58318)

Technalysis CELLEXIS Hematology Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12 (61128)

ANALYTE: Heparin (2518)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Heparin Dose Response (HDR) (2539)

TEST SYSTEM, ASSAY OR EXAMINATION:

International Technidyne Factor VI (28093)

International Technidyne Hemochron 400 (28094)

International Technidyne Hemochron 401 (28095)

International Technidyne Hemochron 800 (28096)

International Technidyne Hemochron 8000 (28298)

International Technidyne Hemochron 801 (28097)

ANALYTE: Plasminogen (4907)

TEST SYSTEM, ASSAY OR EXAMINATION:

Behring Nephelometer II (07563)

Du Pont ACA Star (13357)

ANALYTE: Platelet Count (4908)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I-1600 (28379)

Sysmex K-4500 (58358)

Sysmex K-800 (58307)

Sysmex SE-9000 (58318)

Technalysis CELLEXIS Hematology Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12 (61128)

ANALYTE: Prothrombin Time (PT) (4922)

TEST SYSTEM, ASSAY OR EXAMINATION:

American Bioproducts STA Analyzer (04594)

Behring Fibrintimer A (07516)

Boehringer Mannheim CoaguChek System (07496)

Cardiovascular Diagnostics TAS Analyzer (10257)

Helena Laboratories Cascade M (25156)

HemoTec Automated Coagulation Timer II (25180)

Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)

International Technidyne Factor VI Jr. Microcoagulation (28346)

International Technidyne Factor VI Premier (28296)

International Technidyne Hemochron 8000 (28298)

International Technidyne Hemocrhon Jr. Microcoagulation (28345)

Medical Laboratory MLA Electra 1600C (40167)

Organon Teknika Multi Channel Discrete Analyzer (MDA-180)

(46144)

TOA Medical Electronics CA-1000 (61132)

TOA Medical Electronics CA-5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: Red Blood Cell Count (Erythrocyte Count) (RBC) (5502)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I-1600 (28379)

Sysmex K-4500 (58358)

Sysmex K-800 (58307)

Sysmex SE-9000 (58318)

Technalysis CELLEXIS Hematology Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12 (61128)

ANALYTE: Reticulocyte Count (5506)

TEST SYSTEM, ASSAY OR EXAMINATION:

Becton Dickinson FACSCAN (with retic count software) (07518)

Coulter MAXM (10078)

Coulter STKS (10093)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

ANALYTE: Semen (5822)

TEST SYSTEM, ASSAY OR EXAMINATION:

IRIS IRIScope Body Fld. Cell Count Sys. (sperm enum. only)

(28334)

ANALYTE: Thrombin Time (6105)

TEST SYSTEM, ASSAY OR EXAMINATION:

American Bioproducts STA Analyzer (04594)

Helena Laboratories Cascade M (25156)

Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)

International Technidyne Factor VI Premier (28296)

International Technidyne Factor VI Preimer Throm. Time Plus

(28310)

International Technidyne Factor VI Thrombin Time Plus (28309)

International Technidyne Hemochron 400 HNTT (28299)

International Technidyne Hemochron 400 HiTT (28304)

International Technidyne Hemochron 401 HNTT (28300)

International Technidyne Hemochron 401 HiTT (28305)

International Technidyne Hemochron 800 HNTT (28301)

International Technidyne Hemochron 800 HiTT (28306)

International Technidyne Hemochron 8000 (28298)

International Technidyne Hemochron 8000 HNTT (28303)

International Technidyne Hemochron 8000 HiTT (28308)

International Technidyne Hemochron 801 HNTT (28302)

International Technidyne Hemochron 801 HiTT (28307)

Medical Laboratory MLA Electra 1600C (40167)

TOA Medical Electronics CA-1000 (61132)

TOA Medical Electronics CA-5000 (61135)

Vitek HEMOLAB (67075)

ANALYTE: White Blood Cell Count (Leukocyte Count) (WBC) (7002)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I-1600 (28379)

Sysmex K-4500 (58358)

Sysmex K-800 (58307)

Sysmex SE-9000 (58318)

Technalysis CELLEXIS Hematology Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX (61104)

Texas International Laboratories H12 (61128)

ANALYTE: White Blood Cell Differential (WBC Diff) (7001)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Cell-Dyn 1700 (04607)

Abbott EnCounter (04525)

Alicia Diagnostics Genesis I (04536)

Coulter ONYX (10254)

Coulter ONYX with Autoloader (10281)

DMA H12 (13284)

Danam Datacell 16CP (13363)

Infolab I-1600 (28379)

Sysmex K-4500 (58358)

Sysmex SE-9000 (58318)

Technalysis CELLEXIS Hematology Analyzer (61102)

Technicon H.3 RTC System (61103)

Technicon H.3 RTX System (61104)

Texas International Laboratories H12 (61128)

SPECIALITY/SUBSPECIALITY: Mycology

ANALYTE: Dermatophytes (1302)

TEST SYSTEM, ASSAY OR EXAMINATION:

Biomed Diagnostics InTray DM Medium (07559)

Troy Biologicals Dermatophyte Test Medium (61106)

ANALYTE: Yeast, Candida only (7603) [[Page 25962]]

TEST SYSTEM, ASSAY OR EXAMINATION:

MicroProbe Affirm VPIII Microbial Identification Test (40163)

SPECIALITY/SUBSPECIALITY: Parasitology

ANALYTE: Cryptosprodium (1109)

TEST SYSTEM, ASSAY OR EXAMINATION:

Alexon ProSpecT Cryptosporidum Rapid Assay (dir. Ag/vis.)

(04553)

ANALYTE: Giardia lamblia (2222)

TEST SYSTEM, ASSAY OR EXAMINATION:

Alexon ProSpecT Giardia Rapid Assay (direct antigen/visual)

(04364)

ANALYTE: Scabies (5831)

TEST SYSTEM, ASSAY OR EXAMINATION:

All Direct Wet Mount Preparations (04108)

ANALYTE: Trichomonas (6116)

TEST SYSTEM, ASSAY OR EXAMINATION:

MicroProbe Affirm VPIII Microbial Identification Test (40163)

SPECIALITY/SUBSPECIALITY: Toxicology/TDM

ANALYTE: Acetaminophen (0406)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

GDS Diagnostics Stat-Site Meter (22126)

ANALYTE: Amikacin (0425)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Amphetamines (0428)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Drug Screening Systems microLINE Screens (13259)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign DOA 4 (49130)

ANALYTE: Barbiturates (0701)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

Boehringer Mannheim Hitachi 914 (07546)

Drug Screening Systems microLINE Screens (13259)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

ANALYTE: Benzodiazepines (0702)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

Boehringer Mannheim Hitachi 914 (07546)

Drug Screening Systems microLINE Screens (13259)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

ANALYTE: Cannabinoids (THC) (1009)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign DOA 4 (49130)

Princeton BioMeditech AbuSign THC (49133)

Princeton BioMeditech AccuSign THC (49139)

Princeton BioMeditech BioSign THC (49137)

Princeton BioMeditech DOA-COC (49135)

Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)

ANALYTE: Carbamazepine (1010)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 1800 (28322)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS Magnum (49098)

Seradyn LPIA-100 (58294)

ANALYTE: Carboxyhemoglobin (1012)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ciba Corning 845 (10296)

Ciba Corning 855 (10297)

Ciba Corning 865 (10298)

Radiometer ABL 620 (55137)

ANALYTE: Cocaine Metabolites (1023)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

EDITEK VERDICT COCAINE (16078)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign COC (49132)

Princeton BioMeditech AbuSign DOA 4 (49130)

Princeton BioMeditech AccuSign COC (49138)

Princeton BioMeditech BioSign COC (49136)

Princeton BioMeditech DOA-TCO (49134)

Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

ANALYTE: Digitoxin (1303)

TEST SYSTEM, ASSAY OR EXAMINATION:

Cirrus Diagnostics Immulite (10159)

Du Pont ACA Star (13357)

ANALYTE: Digoxin (1304)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 4 CE (07174)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim ES 300 AL (07524)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 250 (34037)

Kodak Ektachem 950 IRC (34087)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Sanofi Pasteur Access Immunoassay System (58257)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

Vitek Systems Vidas (67038)

Wako Diagnostics 30R (70002)

ANALYTE: Ethanol (Alcohol) (1608)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 950 IRC (34087)

Olympus AU 5041 (46145)

ANALYTE: Ethosuximide (1609)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Gentamicin (2202)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Seradyn LPIA-100 (58294)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Isonicotinic Acid (2819)

TEST SYSTEM, ASSAY OR EXAMINATION:

DynaGen MYCODYN URITEC Test Strips (13264)

ANALYTE: Lidocaine (3710)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Lithium (3712)

TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25963]]

Instrumentation Laboratory ILyte Na, K, Li System (28319)

Ionetics Model 400/450 Electrolyte Analyzer (28324)

Kodak Ektachem 250 (34037)

Kodak Ektachem 400 (34012)

Kodak Ektachem 500 (34013)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 (34014)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 700 P (34024)

Kodak Ektachem 700 XR (34015)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT 60 (34016)

Kodak Ektachem DT II (34057)

Kodak Ektachem DT SC II Module (34028)

Kodak Ektachem DT SC Module (34017)

Kodak Ektachem DTE Module (34018)

Nova 10 (with CRT) (43061)

ANALYTE: Methadone (4003)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel for Drugs of Abuse (07195)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA (13082)

Du Pont ACA II (13172)

Du Pont ACA III (13173)

Du Pont ACA IV (13083)

Du Pont ACA Star (13357)

Du Pont ACA V (13084)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Roche Abuscreen ONTRAK (55099)

ANALYTE: Methamphetamines (4004)

TEST SYSTEM, ASSAY OR EXAMINATION:

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

ANALYTE: Methaqualone (4005)

TEST SYSTEM, ASSAY OR EXAMINATION:

Boehringer Mannheim Hitachi 914 (07546)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

ANALYTE: Methotrexate (4006)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

ANALYTE: Morphine (4020)

TEST SYSTEM, ASSAY OR EXAMINATION:

Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)

Sun Biomedical Labs Visualine II Morphine/Opiates/Heroin (58359)

ANALYTE: N-Acetylprocainamide (NAPA) (4301)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

ANALYTE: Opiates (4601)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidpresnt.

(07528)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

EDITEK VERDICT OPIATES (16077)

Olympus AU 5041 (46145)

Olumpus AU 5121 (46087)

Olympus AU 5200 (46143)

Princeton BioMeditech AbuSign DOA 4 (49130)

Princeton BioMeditech AbuSign Opi (49144)

Princeton BioMeditech AccuSign Opi (49146)

Princeton BioMeditech BioSign Opi (49147)

Princeton BioMeditech DOA-Opi (49145)

ANALYTE: Phencyclidine (PCP) (4901)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

EDITEK EZ-Screen:PCP (16073)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

ANALYTE: Phenobarbital (4902)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Baxter Paramax (07048)

Baxter Paramax 720 (07186)

Baxter Paramax 720 ZX (07049)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Seradyn LPIA-100 (58294)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Phenytoin (4903)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Baxter Paramax (07048)

Baxter Paramax 720 (07186)

Baxter Paramax 720 ZX (07049)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 250 (34037)

Kodak Ektachem 950 IRC (34087)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Primidone (4912)

TEST SYSTEM, ASSAY OR EXAMINATION

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

ANALYTE: Procainamide (4913)

TEST SYSTEM, ASSAY OR EXAMINATION:

Du Pont ACA Star (13357)

PB Diagnostics System OPUS (49001)

ANALYTE: Propoxyphene (4917)

TEST SYSTEM, ASSAY OR EXAMINATION:

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

ANALYTE: Quinidine (5202)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

ANALYTE: Salicylates (5801)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 (IRC (34087)

ANALYTE: Theophylline (6104)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Baxter Paramax (07048)

Baxter Paramax 720 (07186)

Baxter Paramax 720 ZX (07049)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Immunomatrix Theophylline Blood Monitoring System (28318)

Instrumentation Laboratory ILAB 1800 (28323)

Instrumentation Laboratory ILAB 900 (28322)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

Kodak Ektachem DT II (34057)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

Technicon OPERA Clinical Chemistry System (61161)

Vitek Systems Vidas (67038)

ANALYTE: Tobramycin (6112)

TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25964]]

Abbott AxSYM (04532)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Tricyclic Antidepressants (6117)

TEST SYSTEM, ASSAY OR EXAMINATION:

Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt.

(07528)

Du Pont ACA Star (13357)

ANALYTE: Valproic Acid (6701)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Boehringer Mannheim Hitachi 704 (07161)

Boehringer Mannheim Hitachi 717 (07163)

Boehringer Mannheim Hitachi 911 (07377)

Boehringer Mannheim Hitachi 914 (07546)

Ciba Corning Biotrack 516 (10048)

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

Seradyn LPIA-100 (58294)

ANALYTE: Vancomycin (6703)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott AxSYM (04532)

Du Pont ACA Star (13357)

PB Diagnostics Systems OPUS (49001)

PB Diagnostics Systems OPUS Magnum (49097)

PB Diagnostics Systems OPUS PLUS (49098)

SPECIALITY/SUBSPECIALITY: Urinalysis

ANALYTE: Total Solids (Specific Gravity) (6125)

TEST SYSTEM, ASSAY OR EXAMINATION:

ATAGO A300CL Clinical Refractometer (04575)

ATAGO T-2 Clinical Refractometer (04577)

ATAGO UG-1 Digital Urine Specific Gravity Refractometer (04576)

ATAGO URICON-PN Urine Specific Gravity Refractometer (04578)

Ames Clinitek Atlas Automated Urine Analyzer (04527)

IRIS The Yellow IRIS Model 250 (28369)

IRIS The Yellow IRIS Model 450 (28370)

National Instrument Hand Protometer (43085)

ANALYTE: Urine Qualitative Dipstick Chemistries (6406)

TEST SYSTEM, ASSAY OR EXAMINATION:

Ames Clinitek Atlas Automated Urine Analyzer (04527)

Boehringer Mannheim CHEMSTRIP Mini UA Urine Analyzer (07565)

Boehringer Mannheim Chemstrip Super UA Urine Analyzer (07520)

SPECIALITY/SUBSPECIALITY: Virology

ANALYTE: Adenovirus (0410)

TEST SYSTEM, ASSAY OR EXAMINATION:

Orion Diagnostica Diarlex Rota-Adeno (dir. antigen/visual)

(46154)

ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott TestPack Rotavirus (direct antigen/visual) (04516)

Meridian Diagnostics ImmunoCard Rotavirus (40189)

Orion Diagnostica Diarlex Rota-Adeno (dir. antigen/visual)

(46154)

COMPLEXITY: High

SPECIALITY/SUBSPECIALITY: Bacteriology

ANALYTE: Aerobic &/or Anaerobic Organisms-unlimited sources (0412)

TEST SYSTEM, ASSAY OR EXAMINATION:

Alamar Bacterial Identification Panel (including culture)

(04531)

Analytab API 20E/UniScept 20E (including culture) (04513)

Becton Dickinson Crystal E/NF ID System (including culture)

(07485)

Becton Dickinson Crystal RS/E ID System (including culture)

(07484)

Micro Media Sys. Microdilution MIC/ID Panels (inc. culture)

(40201)

Radiometer Microbat 12A & 12A+12B G/neg ID Sys (inc. cult.)

(55115)

Roche Oxi/Ferm II (including culture) (55116)

Vitek Systems Rapid NFT (including culture) (67076)

ANALYTE: Aerobic Organisms from urine specimens only (0468)

TEST SYSTEM, ASSAY OR EXAMINATION:

Adams Scientific Selecticult-U (nonconfirmatory ID) (04548)

BioClinical Systems Bullseye Urine Plate (nonconfirm. ID)

(07539)

Culture Kits, Inc. Uri-Three (nonconfirmatory ID) (10262)

Future Medical Tech. Intl. Qualture (nonconfirmatory ID) (19022)

Innovative Diag. Systems IDS Rapid SS/U (including culture)

(28053)

Troy Biologicals Bacti-Star II Urine Sys. (nonconfirm. ID)

(61142)

Troy Biologicals Bacti-Star Urine Plate (nonconfirm. ID) (61143)

Troy Biologicals Bacti-Urine Plate (nonconfirmatory ID) (61144)

Troy Biologicals Uri-Check Plus (nonconfirmatory ID) (61145)

UTI-tect Bacteriuria Diag. Test System (nonconfirmatory ID)

(64028)

ANALYTE: Chlamydia (1016)

TEST SYSTEM, ASSAY OR EXAMINATION:

DAKO IDEIA Chlamydia (direct Ag/spectrophoto) (13329)

DAKO IDEIA Chlamydia (direct Ag/visual) (13328)

DAKO IMAGEN Chlamydia (direct antigen) (13334)

Gen-Probe PACE 2C System (22171)

Gen-Probe Pace2 Probe Competition Assay (PCA) (dir. Ag) (22166)

NeoGenex C. trachomatis Antigen Test (direct antigen) (43099)

NeoGenex C. trachomatis Antigen Test (inc. cell culture) (43098)

Roche Amplicor Chlamydia Trachomatis Test (55118)

Sanofi Pasteur Chlamydia Micro. EIA Blocking (dir.ag/spec.)

(58330)

Sanofi Pasteur Chlamydia Microplate EIA (dir. ag./spectro.)

(58336)

Syva MicroTrak II Chlamydia EIA Blocking Assay (dir.ag/spec)

(58335)

ANALYTE: Clostridium difficile (1022)

TEST SYSTEM, ASSAY OR EXAMINATION:

Alexon ProSpecT Clostridium difficile (direct Ag/spectro)

(04540)

Alexon ProSpecT Clostridium difficile (direct Ag/visual) (04539)

Becton Dickinson CULTURETTE BRAND Toxin CD (dir. Ag/visual)

(07486)

Becton Dickinson CULTURETTE BRAND Toxin CD (dir. Ag/Spectro)

(07487)

TechLab C. difficile 1-hour TOX-A Test (spectrophotometric)

(61149)

TechLab C. difficile 1-hour TOX-A Test (visual) (61148)

TechLab C. difficile Toxin/Antitoxin Kit (61107)

TechLab Clostridium difficile TOX-B Test (61147)

ANALYTE: Dental plaque (1317)

TEST SYSTEM, ASSAY OR EXAMINATION:

BioScan Video Phase Contrast Microscope (07499)

ANALYTE: Escherichia coli (1604)

TEST SYSTEM, ASSAY OR EXAMINATION:

Remel E. coli 0157:H7 Latex Test (including culture) (55125)

ANALYTE: Legionella (3706)

TEST SYSTEM, ASSAY OR EXAMINATION:

Binax Legionella Urinary Antigen EIA (07527)

ANALYTE: N. gonorrhoeae (from urogenital or rectal only) (4317)

TEST SYSTEM, ASSAY OR EXAMINATION:

Gen-Probe PACE 2C System (22171)

ANALYTE: Neisseria gonorrhoeae (4302)

TEST SYSTEM, ASSAY OR EXAMINATION:

E-Y Laboratories Gonochek-II Kit (16027)

ANALYTE: Salmonella (5802)

TEST SYSTEM, ASSAY OR EXAMINATION:

SMI MED. Salmonella O Grouping (including culture) (58255)

ANALYTE: Staphyococcus (5807)

TEST SYSTEM, ASSAY OR EXAMINATION:

Trinity Laboratories STAPH-A-LEX System (including Culture)

(61129)

Unipath Staphytect-OD (including culture) (64030)

ANALYTE: Streptococcus pneumoniae (5808)

TEST SYSTEM, ASSAY OR EXAMINATION:

AB Biodisk Etest for S. pneumoniae (including culture) (04561)

ANALYTE: Streptococcus, group A (5810)

TEST SYSTEM, ASSAY OR EXAMINATION:

Becton Dickinson Precise STREP A (including culture) (07427)

Gen-Probe Group A Streptococcus Direct Test

(22165) [[Page 25965]]

Pro-lab Prolex Streptococcal Grouping Latex (inc. culture)

(49116)

Remel RIM Strep Grouping LA Test (including culture) (55139)

Syntron QuikPac Strep A (EIA) Test (including culture) (58293)

ANALYTE: Streptococcus, group B (5811)

TEST SYSTEM, ASSAY OR EXAMINATION:

Pacific Biotech Cards O.S. Strep B. (including culture) (49115)

Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture)

(49116)

Remel RIM Strep Grouping LA Test (including culture) (55139)

ANALYTE: Streptococcus, group C (5812)

TEST SYSTEM, ASSAY OR EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture)

(49116)

Remel RIM Strep Grouping LA Test (including culture) (55139)

ANALYTE: Streptococcus, group D (5813)

TEST SYSTEM, ASSAY OR EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture)

(49116)

ANALYTE: Streptococcus, group F (5814)

TEST SYSTEM, ASSAY OR EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture)

(49116)

Remel RIM Strep Grouping LA Test (including culture) (55139)

ANALYTE: Streptococcus, group G (5815)

TEST SYSTEM, ASSAY OR EXAMINATION:

Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture)

(49116)

Remel RIM Strep Grouping LA Test (including culture) (55139)

SPECIALITY/SUBSPECIALITY: Endocrinology

ANALYTE: 17 OH Progesterone, Neonatal (0103)

TEST SYSTEM, ASSAY OR EXAMINATION:

Wallac Oy DELFIA Neo-17a-OHP Kit (70157)

ANALYTE: 17 alpha-OH Progesterone (0109)

TEST SYSTEM, ASSAY OR EXAMINATION:

Pantex NeoScreen ELISA 17 alpha-Hydroxyprogesterone (49124)

ANALYTE: 5-Hydroxyindolacetic Acid, Urine (5-HIAA) (0101)

TEST SYSTEM, ASSAY OR EXAMINATION:

esa Coulochem Electrode Array System (CEAS) (16043)

ANALYTE: Adrenocorticotropic Hormone (ACTH) (0458)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence ACTH Assay (43074)

ANALYTE: Aldosterone (0459)

TEST SYSTEM, ASSAY OR EXAMINATION:

Diagnostic Systems DSL Active Aldosterone RIA Kit (13315)

ANALYTE: Catecholamines, Urine (1055)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bioanalytical Systems Urinary Catecholamine Kit (07560)

ANALYTE: Cortisol (1032)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence Cortisol Assay (43082)

Wallac Oy DELFIA Cortisol Kit (70159)

elias usa Synelisa Cortisol (16048)

ANALYTE: Cortisol, Urine (extraction procedure) (1095)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott TDX (04071)

Abbott TDX FLx (04072)

Sanofi Pasteur Access Immunoassay System (58257)

Vitek Systems Vidas (67038)

ANALYTE: Dehydroepiandrosterone (DHEA) (1309)

TEST SYSTEM, ASSAY OR EXAMINATION:

Diagnositic Systems DSL-9000 Active DHEA RIA Kit (13309)

Nichols Institute Chemiluminescence DHEA Assay (43079)

elias usa Synelisa DHEA Sulfate EIA Kit (16062)

ANALYTE: Dehydroepiandrosterone Sulfate (DHEA-SO4) (1310)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence DHEA-S Assay (43083)

ANALYTE: Erythropoietin (1611)

TEST SYSTEM, ASSAY OR EXAMINATION:

Genzyme Predicta Erythropoietin Kit (22159)

Nichols Institute Cheiluminescence Erythropoietin Assay (43100)

R & D Systems Quantikine Erythropoietin ELISA (55114))

R & D Systems Quantikine IVD Erythropoietin ELISA (55132)

ANALYTE: Estradiol (1605)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad CoTube (07138)

Clinical Assays GammaCoat (10060)

Diagnostic Products Corp. Coat-a-Count Estradiol-6 (13317)

Wallac Oy DELFIA Estradiol Kit (70148)

ANALYTE: Estrone (1628)

TEST SYSTEM, ASSAY OR EXAMINATION:

Diagnostic Systems Estrone RIA Kit (13314)

ANALYTE: Follicle Stimulating Hormone (FSH) (1908)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence FSH Assay (43066)

Roche Cobas Core FSH EIA (manual procedure) (55124)

SeaLite Sciences AquaLite FSH (58342)

Wallac Oy DELFIA hFSH Kit (70149)

ANALYTE: HCG, Beta, Serum, Quantitative (2502)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence HCG Assay (43081)

SeaLite Sciences AquaLite hCG (58340)

Wallac Oy DELFIA hCG Kit (70147)

ANALYTE: Homovanillic Acid (HVA) (2545)

TEST SYSTEM, ASSAY OR EXAMINATION:

esa Coulochem Electrode Array System (CEAS) (16043)

ANALYTE: Human Growth Hormone (GH) (2547)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence HGH Assay (43068)

Wallac Oy DELFIA hGH Kit (70162)

ANALYTE: Insulin-like Grwth Factor Bind. Protein3 (IGFBP-3) (2832)

TEST SYSTEM, ASSAY OR EXAMINATION:

Diagnostic Systems Active IGFBP-3 IRMA Kit (13375)

Diagnostic Systems DSL-6700 IGFBP-3 RIA Kit (13310))

Endocrine Sciences IGFBP-3 RIA Kit (16060)

ANALYTE: Luteinizing Hormone (LH) (3713)

TEST SYSTEM, ASSAY OR EXAMINATION:

ICN ImmuChem LH-MW Elisa Kit (28269)

Roche Cobas Core LH EIA (manual procedure) (55121)

SeaLite Sciences AquaLite LH (58339)

Wallac Oy DELFIA hLH Kit (70150)

Wallac Oy DELFIA hLH Spec Kit (70151)

ANALYTE: Parathyroid Hormone--Intact (4924)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad CoTube (07138)

Diagnostic Products Corp. Coat-A-Count (13030)

Immunodiagnostic Systems ltd Gamma-BCT Intact PTH (28351)

Immunodiagnostic Systems ltd OCTEIA Intact PTH (28350)

Nichols Institute Chemiluminescence PTH Assay (43080)

ANALYTE: Progesterone (4914)

TEST SYSTEM, ASSAY OR EXAMINATION:

CyberFluor FIAgen Progesterone Assay Kit (10261)

Immunotech Progesterone RIA Kit (28325)

Wallac Oy DELFIA Progesterone Kit (70153)

elias usa Synelisa Progesterone (16046)

ANALYTE: Prolactin (4915)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott RIA Bead (04061)

Nichols Institute Chemiluminescence Prolactin Assay (43069)

Roche Cobas Core Prolactin EIA (manual procedure) (55122)

Wallac Oy DELFIA Prolactin Kit (70152)

ANALYTE: Renin (5515)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute BV Active Renin RIA (43062)

ANALYTE: Sex Hormone Binding Globulin (5819)

TEST SYSTEM, ASSAY OR EXAMINATION:

Wallac Oy DELFIA SHBG Kit (70154)

ANALYTE: Testosterone (6102) [[Page 25966]]

TEST SYSTEM, ASSAY OR EXAMINATION:

Wallac Oy DELFIA Testosterone Kit (70155)

ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence TSH Assay (43065)

Roche Cobas Core TSH EIA (manual procedure) (55129)

STC Diagnostics TSH Micro-Plate EIA (58308)

SeaLite Sciences AquaLite TSH (58350)

Wallac Oy DELFIA hTSH Kit (70142)

ANALYTE: Thyroid Stimulating Hormone (TSH) (Neonatal) (6107)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bioclone ELEGANCE Neonatal TSH ELISA (computer calculate)

(07555)

Bioclone ELEGANCE Neonatal TSH ELISA (manual calculations)

(07554)

Pantex NEOSCREEN ELISA TSH (49126)

Wallac Oy DELFIA Neo-hTSH Kit (70156)

ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Tetrabead-125 (04519)

Becton Dickinson SimulTRAC (07106)

Nichols Institute Chemiluminescence Total T4 Assay (43070)

Roche Cobas Core T4 EIA (manual procedure) (55131)

Wallac Oy DELFIA T4 Kit (70145)

ANALYTE: Thyroxine Binding Globulin (TBG) (6110)

TEST SYSTEM, ASSAY OR EXAMINATION:

Wallac Oy DELFIA TBG Kit (70146)

ANALYTE: Thyroxine, Free (FT4) (6111)

TEST SYSTEM, ASSAY OR EXAMINATION:

Immunotech Free T4 RIA Kit (28326)

Nichols Institute Chemiluminescence Free T4 Assay (43071)

Roche Cobas Core FT4 EIA (manual procedure) (55128)

STC Diagnostics Free T-4 Micro-Plate EIA (58289)

Wallac Oy DELFIA Free T4 Kit (70143)

ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY OR EXAMINATION:

Monobind Coated Tube RIA Test System (40164)

Nichols Institute Chemiluminescence Total T3 Assay (43072)

Roche Cobas Core T3 EIA (manual procedure) (55130)

Wallac Oy DELFIA T3 Kit (70144)

ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence T3 Uptake Assay (43087)

ANALYTE: Triiodothyronine, Free (FT3) (6121)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence Free T3 Assay (43078)

ANALYTE: Vanillylmandelic Acid (VMA) (6710)

TEST SYSTEM, ASSAY OR EXAMINATION:

esa Coulochem Electrode Array System (CEAS) (16043)

SPECIALITY/SUBSPECIALITY: General Chemistry

ANALYTE: 1-Methylhistidine (0107)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: 3-Methylhistidine (0108)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Alanine (0511)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)

TEST SYSTEM, ASSAY OR EXAMINATION:

STC Diagnostics ALT Micro-Plate Assay (58337)

ANALYTE: Albumin (0414)

TEST SYSTEM, ASSAY OR EXAMINATION:

Trace Scientific Albumin BCG Modified Reactivity (Manual)

(61118)

ANALYTE: Alkaline Phosphatase (ALP) (0416)

TEST SYSTEM, ASSAY OR EXAMINATION:

Hybritech Tandem-R Ostase (25170)

Synermed Test Kit (58260)

ANALYTE: Alpha-Amino-n-butyric Acid (0512)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Alpha-Aminoadipic Acid (0510)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Aminoethylcysteine (0513)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Ammonia, Plasma/Serum (0427)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bekman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Amylase (0429)

TEST SYSTEM, ASSAY OR EXAMINATION:

Genzyme Test Kit (22164)

Intersect Systems Test Kit (28321)

Pointe Scientific Manual Amylase Test (49103)

Synermed Test Kit (58260)

TECO Diagnostics Amylase Reagent Set (manual procedure) (61156)

ANALYTE: Angiotensin Converting Enzyme (ACE) (0481)

TEST SYSTEM, ASSAY OR EXAMINATION:

ALPCO Angiotensin Converting Enzyme REA (04562)

ANALYTE: Anserine (0514)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Apolipoprotein A1 (0462)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence APO-A1 Assay (43077)

ANALYTE: Apolipoprotein B (0457)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence APO-B Assay (43073)

ANALYTE: Arginine (0515)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Asparagine (0509)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Aspartic Acid (0508)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Beta-Alanine (0732)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Beta-Aminoisobutyric Acid (0733)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Bilirubin, Direct (0704)

TEST SYSTEM, ASSAY OR EXAMINATION:

Horizon Direct Bilirubin Manual Procedure (25151)

Synermed Test Kit (58260)

ANALYTE: Carbon Dioxide, Total (C02) (1003)

TEST SYSTEM, ASSAY OR EXAMINATION:

Intersect Systems Test Kit (28321)

ANALYTE: Carnosine (1108)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY OR EXAMINATION:

King Diagnostics Test Kit (34051)

Randox Laboratories Test Kit (55106)

ANALYTE: Cholyglycine (Bile Acids) (1053)

TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25967]]

Abbott CG RIA Kit (04517)

ANALYTE: Citrulline (1105)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Creatine Kinase (CK) 1034)

TEST SYSTEM, ASSAY OR EXAMINATION:

King Diagnostics Test Kit (34051)

Pointe Scientific Manual Creatine Kinase Test (49104)

Randox Laboratories CK NAC-activated Test Kit (55117)

Synermed Test Kit (58260)

ANALYTE: Creatine Kinase Isoenzymes (CK Isoenzymes) (1052)

TEST SYSTEM, ASSAY OR EXAMINATION:

Helena Laboratories REP E-Z CK-30 Isoenzyme Procedure (25153)

ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)

TEST SYSTEM, ASSAY OR EXAMINATION:

CHEMROY Creatine Kinase-MB (CK-MB) Reagent Set (10280)

Diagnostic Chemicals Ltd. Assay Kit (13210)

Helena Laboratories Cardio REP CK Isoenzyme Procedure (25139)

Helena Laboratories Cardio REP CK Isoforms Procedure (25140)

Pointe Scientific Creatine Kinase-MB (manual procedure) (49117)

ANALYTE: Creatinine (1035)

TEST SYSTEM, ASSAY OR EXAMINATION:

Synermed Test Kit (58260)

ANALYTE: Cystathionine (1107)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Cystine (1106)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Ethanolamine (1629)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY OR EXAMINATION:

Nichols Institute Chemiluminescence Ferritin Assay (43067)

Roche Cobas Core Ferritin EIA (manual procedure) (55123)

Wallac Oy DELFIA Ferritin Kit (70161)

ANALYTE: Folate (Folic acid) (1907)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad Quantaphase II (07532)

ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)

TEST SYSTEM, ASSAY OR EXAMINATION:

King Diagnostics Test Kit (34051)

Synermed Test Kit (58260)

ANALYTE: Gamma-Aminobutyric Acid (2220)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glutamic Acid (2217)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glutamine (2218)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glycine (2219)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)

TEST SYSTEM, ASSAY OR EXAMINATION:

LSI ASCA Chemistry System (37069)

Pointe Scientific Glycohemoglobin Test Kit (49114)

Primus Rapid Gel Glycated Hemoglobin (49129)

TECO Glycohemoglobin Kit (61141)

ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

Intersect Systems Test Kit (28321)

Olympus AU 5041 (46145)

Olympus AU 5121 (46087)

Olympus AU 5200 (46143)

Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Hemoglobin C (2559)

TEST SYSTEM, ASSAY OR EXAMINATION:

Isolab HemoCard Hemoglobin C Assay (28340)

ANALYTE: Hemoglobin E (2556)

TEST SYSTEM, ASSAY OR EXAMINATION:

Isolab HemoCard Hemoglobin E (28268)

ANALYTE: Hemoglobin Fractions (2544)

TEST SYSTEM, ASSAY OR EXAMINATION:

Helena Laboratories REP Alkaline Hb-15 (25144)

ANALYTE: Hemoglobin S (2536)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad Variant (07498)

Isolab Quik-Sep Quantitative Hemoglobin S Assay (28353)

ANALYTE: Histidine (2563)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Homocystine (2561)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Hydroxylysine (2562)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Hydroxyproline (2560)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Iron (2814)

TEST SYSTEM, ASSAY OR EXAMINATION:

King Diagnostics Test Kit (34051)

Sigma Diagnostics Test Kit (58051)

ANALYTE: Iron Binding Capacity (post saturation/separation) (2815)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott Spectrum CCX (04515)

Beckman Synchron CX 5 CE (07491)

Boehringer Mannheim Hitachi 914 (07546)

Du Pont ACA Star (13357)

Du Pont Dimension XL (13355)

King Diagnostics Test Kit (34051)

Kodak Ektachem 550 XRC Analyzer (34056)

Kodak Ektachem 700 Analyzer C Series (34054)

Kodak Ektachem 750 XRC Analyzer (34055)

Kodak Ektachem 950 IRC (34087)

LSI ASCA Chemistry System (37069)

Olympus AU 5041 (46145)

Olympus AU 5200 (46143)

ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)

TEST SYSTEM, ASSAY OR EXAMINATION:

Sigma Diagnostics Test Kit (58051)

ANALYTE: Isoleucine (2833)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Lactate Dehydrogenase (LDH) (3701)

TEST SYSTEM, ASSAY OR EXAMINATION:

HiChem LDH/L Reagent Kit (manual) (25183)

ANALYTE: Lactate Dehydrogenase Isoenzymes (3721)

TEST SYSTEM, ASSAY OR EXAMINATION:

Helena Laboratories Cardio REP LD Isoenzyme Procedure (25169)

ANALYTE: Leucine (3749)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Lipase (3711)

TEST SYSTEM, ASSAY OR EXAMINATION:

Meditech Diagnostic System Test Kit (40118)

NuClin Diagnostics ElIpAse (43090)

Sigma Diagnostics Lipase-PS (manual procedure) (58323)

ANALYTE: Lipoprotein Fractions (3720)

TEST SYSTEM, ASSAY OR EXAMINATION:

Helena Laboratories REP Direct-Sep Cholesterol

(25179) [[Page 25968]]

Helena Laboratories REP HDL/LDL-30 Electrophoresis System

(25168)

ANALYTE: Lysine (3750)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Magnesium (4002)

TEST SYSTEM, ASSAY OR EXAMINATION:

Horizon Diagnostics Magnesium (manual procedure) (25178)

King Diagnostics Test Kit (34051)

ANALYTE: Methionine (4031)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Microalbumin (4019)

TEST SYSTEM, ASSAY OR EXAMINATION:

Synermed IR 500 (58322)

ANALYTE: Microprotein, CSF (4026)

TEST SYSTEM, ASSAY OR EXAMINATION:

DMA Test Kit (13216)

Sterling Diagnostics Test Kit (58230)

ANALYTE: Microprotein, Urine (4027)

TEST SYSTEM, ASSAY OR EXAMINATION:

DMA Test Kit (13216)

Sterling Diagnostics Test Kit (58230)

TRACE Scientific Test Kit (61044)

ANALYTE: Ornithine (4606)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Phenylalanine (4942)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ICN ImmuChem Phenylalanine Microwell Enzyme Assay (28384)

Porton Cambridge Quantase Phenylalanine Assay (49125)

ANALYTE: Phosphoethanolamine (4970)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Phosphoserine (4969)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Proline (4971)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Protein, Glycated (4963)

TEST SYSTEM, ASSAY OR EXAMINATION:

Diagnostic Specialties Protein-Bound Glucose Assay Kit (13286)

ANALYTE: Protein, Total (4921)

TEST SYSTEM, ASSAY OR EXAMINATION:

STC Diagnostics Total Protein Micro-Plate Assay (58347)

ANALYTE: Proteolytic enzymes (4965)

TEST SYSTEM, ASSAY OR EXAMINATION:

Advanced Clinical Tech. Periocheck Enzyme Activity Kit (04526)

ANALYTE: Sarcosine (5835)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Serine (5834)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Surfactant/Albumin Ratio (5833)

TEST SYSTEM, ASSAY OR EXAMINATION:

Abbott TDX (04071)

Abbott TDX FLx (04072)

ANALYTE: Taurine (6141)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Threonine (6141)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Transferrin (6114)

TEST SYSTEM, ASSAY OR EXAMINATION:

TRACE Scientific Test Kit (61044)

ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY OR EXAMINATION:

Randox Laboratories Test Kit (55106)

ANALYTE: Trypsin (6129)

TEST SYSTEM, ASSAY OR EXAMINATION:

NuClin Diagnostics NuCliTryp RIA (43089)

ANALYTE: Tryptophan (6144)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Tyrosine (6143)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Urea (BUN) (6403)

TEST SYSTEM, ASSAY OR EXAMINATION:

AMRESCO BUN Reagent (manual procedure) (04554)

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Uric Acid (6404)

TEST SYSTEM, ASSAY OR EXAMINATION:

Randox Laboratories Test Kit (55106)

Synermed Test Kit (58260)

ANALYTE: Valine (6717)

TEST SYSTEM, ASSAY OR EXAMINATION:

Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Vitamin B12 (6707)

TEST SYSTEM, ASSAY OR EXAMINATION:

Bio-Rad Quantaphase II (07532)

SPECIALITY/SUBSPECIALITY: General Immunology

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