[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Notices]
[Pages 17832-17849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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

AGENCY: Centers for Disease Control and Prevention (CDC), HHS.

ACTION: Notice with comment period.

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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.
    This Notice announces the addition of approximately 1,300 test 
systems, assays, and examinations that have been categorized and 
notified between June 7, 1996 and December 31, 1996. These 
categorizations were effective on the issue date of the notification 
letter sent to the manufacturer and are subject to the 30 day comment 
period for this Notice.

DATES: Effective date: All categorizations in this Notice 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 May 12, 1997. 
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 in this Notice 
should be addressed to CLIA Federal Register Notice, Centers for 
Disease Control and Prevention, Mail Stop F-11, 4770 Buford Highway, 
NE, Atlanta, Georgia 30341-3724.
    Requests for test complexity categorization should be submitted to: 
Attention: Test Categorization/CLIA, Centers for Disease Control and 
Prevention, Mail Stop F-11, 4770 Buford Highway, NE, Atlanta, Georgia 
30341-3724.

[[Page 17833]]

    Requests for waiver status should be submitted to: Attention: 
Request for Waiver Status/CLIA, Centers for Disease Control and 
Prevention, Mail Stop F-11, 4770 Buford Highway, NE, Atlanta, GA 30341-
3724.
    We will not be accepting facsimile (fax) copies or comments by 
telephone.

FOR FURTHER INFORMATION CONTACT: Rosemary C. Bakes-Martin, (770) 488-
7655.

SUPPLEMENTARY INFORMATION: All requests for test categorization 
should be submitted to the CDC. CDC is reviewing submissions for 
test categorization concurrently with the FDA's review process for 
510(k) clearance or Pre-Market Approval (PMA) clearance. In order 
to assure timely review by CDC, manufacturers are requested to 
submit the package insert and 510(k) number for the product to CDC 
when the product is submitted to the FDA. However, CDC will not be 
able to issue the test categorization until the FDA has finished 
its review process. CDC is currently issuing test categorization 
notification letters to manufacturers within one week of the FDA 
510(k) or PMA clearance. Test categorizations are effective as of 
the date of notification to the applicant. The CDC will publish 
updates and revisions to the test categorization list periodically 
in the Federal Register with opportunity for comment. The CDC will 
also maintain an updated list of categorized tests electronically, 
available to the public via Internet. For further information 
regarding this capability, please call (770) 488-7655.

Comments and Responses

    On July 8, 1996, a test list of approximately 2,400 additional test 
systems, assays, and examinations categorized by level of complexity 
was published in the Federal Register (61 FR 35736) with a 30 day 
comment period. CDC received no comment letters in regard to this 
Notice.

Analyte Clarification

    Confusion has arisen over the nomenclature and related specialty/
subspecialty of the analytes (2512) Helicobacter pylori in the 
specialty/subspecialty of Bacteriology and (2513) Helicobacter pylori 
Antibodies in the specialty/subspecialty of General Immunology. The 
analyte (2512) Helicobacter pylori is used with those test systems that 
detect urease production by the Helicobacter pylori organism in a 
tissue specimen which is considered a bacteriology procedure. The 
analyte (2513) Helicobacter pylori Antibodies is used for the detection 
of antibodies to Helicobacter pylori in serum which is considered an 
immunology procedure.
    For better definition, and where appropriate, a new analyte, (0525) 
Anti-Proteinase (PR-3) Antibodies, has replaced the less specific 
analyte (0440) Anti-Neutrophil Cytoplasm Antibodies.
    For accuracy, the analyte (4973) Protein C Resistance has been 
changed to (0526) Activated Protein C (APC) Resistance.

    Dated: April 3, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).

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, EXAMINATION:

    Becton Dickinson BACTEC 9050 (07809)
ANALYTE: Clostridium difficile (1022)

TEST SYSTEM ASSAY, EXAMINATION:

    Meridian Diagnostics ImmunoCard Toxin A (dir. sample/vis) (40255)
    Unipath Clearview C. DIFF A (64033)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Streptococcus, group A (from throat only) (5828)

TEST SYSTEM ASSAY, EXAMINATION:

    CliniCare CliniStrip NOW Strep A (10386)
    CliniCare CliniStrip Strep A (10385)
SPECIALITY/SUBSPECIALITY: Endocrinology
ANALYTE: Cortisol (1032)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Cortisol, Urine (direct procedure) (1033)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
ANALYTE: Estradiol (1605)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Follicle Stimulating Hormone (FSH) (1908)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade aca Star with aca plus Immunoassay System (13424)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: HCG Beta Serum, Quantitative--Extended Range (ER) (2566)

TEST SYSTEM, ASSAY, EXAMINATION:

    Technicon Immuno 1 System (61042)
ANALYTE: HCG, Beta, Serum, Quantitative (2502)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade aca Star with aca plus Immunoassay System (13424)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: HCG, Serum, Qualitative (2501)

TEST SYSTEM, ASSAY, EXAMINATION:

    Biocircuits IOS (07745)
    Bionike A/Q Pregnancy Test (07779)
    CliniCare CliniStrip hCG Combo (10384)
    Genzyme Contrast Strip hCG (22185)

[[Page 17834]]

    Orion Diagnostica UniStep hCG II (46224)
ANALYTE: HCG, Total, Serum, Quantitative (2555)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Biocircuits IOS (07745)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
ANALYTE: HCG, Urine, Qualitative (non-waived procedures) (2503)

TEST SYSTEM, ASSAY, EXAMINATION:

    TECO Diagnostics Monoclonal B-hCG Pregancy Test (Indirect) (61255)
ANALYTE: HCG, Urine, Quantitative (2534)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
ANALYTE: Luteinizing Hormone (LH) (3713)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade aca Star with aca plus Immunoassay System (13424)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Progesterone (4914)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
ANALYTE: Prolactin (4915)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade aca Star with aca plus Immunoassay System (13424)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: T Uptake (TU) (6156)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Testosterone (6102)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Cirrus Diagnostics Immulite (10159)
    Technicon Immuno 1 System (61042)
ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Biocircuits IOS (07745)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    CliniCare CliniStrip ThyroChek TSH (10387)
    Dade aca Star with aca plus Immunoassay System (13424)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Thyroxine, Free (FT4) (6111)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Du Pont ACA IV with aca plus Immunoassay System (13254)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
ANALYTE: Triiodothyronine, Free (FT3) (6121)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    TOSOH A1A-1200 (61040)
    TOSOH A1A-1200DX (61154)
    TOSOH A1A-600 (61039)
    Technicon Immuno 1 System (61042)
SPECIALITY/SUBSPECIALITY: General Chemistry
ANALYTE: 5'Nucleotidase (0105)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Acid Phosphatase (0407)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)

[[Page 17835]]

    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Albumin (0414)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Albumin, Urinary (0516)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Alkaline Phosphatase (ALP) (0416)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Alpha-Hydroxybutyrate Dehydrogenase (HBDH) (0419)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
ANALYTE: Ammonia, Plasma/Serum (0427)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 570 Alliance (10359)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Amylase (0429)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Angiotensin Converting Enzyme (ACE) (0481)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Apolipoprotein A1 (0462)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Apolipoprotein B (0457)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Aspartate Aminotransferase (AST) (SGOT) (0405)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Beta-Hydroxybutyrate (0722)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Bilirubin, Direct (0704)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Bilirubin, Neonatal (0705)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Bilirubin, Total (0706)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Bilirubin, Urine (0738)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
ANALYTE: Blood Gases with pH (0708)

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL Compact 3 (04680)
    Chiron Diagnostics 170 (10342)
    Chiron Diagnostics 178 (10343)
    Chiron Diagnostics 238 (10344)
    Chiron Diagnostics 248 (10345)
    Chiron Diagnostics 278 (10348)
    Chiron Diagnostics 280 (10349)
    Chiron Diagnostics 288 (10350)
    Chiron Diagnostics 348 System (10337)
    Chiron Diagnostics 400 System (10338)
    Chiron Diagnostics 840 (10369)
    Chiron Diagnostics 845 (10370)
    Chiron Diagnostics 850 (10371)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 860 (10373)
    Chiron Diagnostics 865 (10374)
    Instrumentation Laboratory IL Synthesis (28466)
    Mallinckrodt Gem Premier Plus (40254)
ANALYTE: Calcium, Ionized (1004)

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL 9180 (04664)
    Chiron Diagnostics 288 (10350)
    Chiron Diagnostics 348 System (10337)
    Chiron Diagnostics 400 System (10338)
    Chiron Diagnostics 634 (10365)
    Chiron Diagnostics 850 (10371)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 860 (10373)
    Chiron Diagnostics 865 (10374)
    Instrumentation Laboratory IL

[[Page 17836]]

Synthesis (28466)
    Mallinckrodt Gem Premier Plus (40254)
ANALYTE: Calcium, Total (1005)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Carbon Dioxide, Total (CO2) (1003)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Chiron Diagnostics 664 FAST 4 (10368)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Cerebrospinal Fluid (CSF) Protein (1014)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Chloride (1018)

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL 9180 (04664)
    Chiron Diagnostics 288 (10350)
    Chiron Diagnostics 400 System (10338)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Chiron Diagnostics 644 (10366)
    Chiron Diagnostics 664 FAST 4 (10368)
    Chiron Diagnostics 850 (10371)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 860 (10373)
    Chiron Diagnostics 865 (10374)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Instrumentation Laboratory IL Synthesis (28466)
ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Cholinesterase (1021)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Roche Cobas Mira (55044)
    Roche Cobas Mira S (55045)
ANALYTE: Cholyglycine (Bile Acids) (1053)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Creatine Kinase (CK) (1034)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Vitek Systems Vidas (67038)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Creatinine (1035)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer DCA 2000+ Analyzer (07827)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade aca Star with aca plus Immunoassay System (13424)
    Roche Cobas INTEGRA (55179)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Folate (Folic acid) (1907)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    TOSOH A1A-1200 (61040)
    TOSOH A1A-1200DX (61154)
    TOSOH A1A-600 (61039)
ANALYTE: Folate, Red Blood Cell (RBC Folate) (1930)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
ANALYTE: Fructosamine (1914)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 4 (07071)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 (07072)
    Beckman Synchron CX 5 CE (07491)
    Beckman Synchron CX 7 (07073)
ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express

[[Page 17837]]

      (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Glucose (2203)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 400 System (10338)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Chiron Diagnostics 860 (10373)
    Chiron Diagnostics 865 (10374)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Instrumentation Laboratory IL Synthesis (28466)
ANALYTE: Glucose, Urine (2225)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
ANALYTE: Glucose-6-Phosphate Dehydrogenase (G-6-PDH) (2208)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad DiaSTAT Analyzer (07817)
    Chiron Diagnostics Model 765 Glycomat (10380)
    Roche Cobas INTEGRA (55179)
    Technicon OPERA Clinical Chemistry System (61161)
    Technicon RA 1000 (61010)
    Technicon RA 2000 (61011)
    Technicon RA 500 (61012)
    Technicon RA XT (61013)
ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 704/BM Direct HDL (07818)
    Boehringer Mannheim Hitachi 717/BM Direct HDL (07819)
    Boehringer Mannheim Hitachi 717/Genzyme N-geneous HDL (07812)
    Boehringer Mannheim Hitachi 736/Genzyme N-geneous HDL (07813)
    Boehringer Mannheim Hitachi 747/BM Direct HDL (07820)
    Boehringer Mannheim Hitachi 747/Genzyme N-geneous HDL (07814)
    Boehringer Mannheim Hitachi 911/BM Direct HDL (07821)
    Boehringer Mannheim Hitachi 911/Genzyme N-geneous HDL (07811)
    Boehringer Mannheim Hitachi 914/BM Direct HDL (07822)
    Boehringer Mannheim Hitachi 917/BM Direct HDL (07823)
    Boehringer Mannheim Hitachi 917/Genzyme N-geneous HDL (07815)
    Chiron Diagnostics 550 Express (DMA One Shots) (10353)
    Chiron Diagnostics 550 Express (MHS SPINPRO) (10355)
    Chiron Diagnostics 550 Express (Ref Diag Magnetic HDL Sep) (10356)
    Chiron Diagnostics 550 Express (Sigma ISOSPIN) (10357)
    Chiron Diagnostics 550 Express (T-Am. Singles) (10358)
    Chiron Diagnostics 570 Alliance (MHS SPINPRO) (10360)
    Chiron Diagnostics 570 Alliance (Sigma ISOSPIN) (10361)
    Chiron Diagnostics 580 Alliance (MHS SPINPRO) (10363)
    Dade Analyst (13425)
    Olympus AU 5200/Genzyme N-geneous HDL (46223)
    Olympus AU 800/Genzyme N-geneous HDL (46222)
    Roche Cobas FARA/Genzyme N-geneous HDL (55213)
    Roche Cobas Mira/Genzyme N-geneous HDL (55212)
    Technicon DAX 96/Genzyme N-geneous HDL (61259)
ANALYTE: Haptoglobin (2511)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman IMMAGE Immunochemistry System (07816)
    Chiron Diagnostics 550 Express (10352)
ANALYTE: Hemoglobin A2 (2535)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics Model 765 Glycomat (10380)
ANALYTE: Hemoglobin Barts (2537)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad Variant/Alpha Thalassemia Short Program (07791)
ANALYTE: Hemoglobin Fractions (2544)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics Model 765 Glycomat (10380)
ANALYTE: Hemoglobin S (2536)

TEST SYSTEM, ASSAY, EXAMINATION:

    SA Scientific SAS Sickle Cell Test (58420)
ANALYTE: Iron (2814)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Spectrum (04067)
    Abbott Spectrum EPX (04068)
    Abbott Spectrum Series II (04069)
    Beckman Synchron CX 3 (07070)
    Beckman Synchron CX 4 (07071)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 4 Delta (07762)
    Beckman Synchron CX 5 (07072)
    Beckman Synchron CX 5 CE (07491)
    Beckman Synchron CX 5 Delta (07763)
    Beckman Synchron CX 7 (07073)
    Beckman Synchron CX 7 Delta
      (07764)
    Chiron Diagnostics 550 Express (10352)
    Ciba Corning 550 Express (10038)
    Coulter Optichem 100 (10115)
    Coulter Optichem 120 (10079)
    Coulter Optichem 180 (10080)
    Instrumentation Laboratory IL Monarch 1000 (28082)
    Instrumentation Laboratory IL Monarch 2000 (28231)
    Instrumentation Laboratory IL Monarch Plus (28083)
    Olympus Reply (46089)
    Technicon RA 1000 (61010)
    Technicon RA 500 (61012)
    Technicon RA XT (61013)
ANALYTE: Ketone, Urine (3404)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
ANALYTE: LDL Cholesterol (3748)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (Genzyme immunosep tube) (10354)
ANALYTE: Lactate Dehydrogenase (LDH) (3701)

[[Page 17838]]

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Lactate Dehydrogenase Heart Fraction (LDH-1) (3702)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
ANALYTE: Lactate Dehydrogenase Liver Fraction (LLDH) (3703)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Lactic Acid (Lactate) (3704)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 860 (10373)
    Chiron Diagnostics 865 (10374)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Lipase (3711)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Magnesium (4002)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Methemoglobin (4032)

TEST SYSTEM, ASSAY, EXAMINATION:

    A-VOX Systems AVOXimeter 4000 (04678)
    Chiron Diagnostics 845 (10370)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 865 (10374)
    Instrumentation Laboratory IL Synthesis (28466)
ANALYTE: Microalbumin (4019)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer DCA 2000+ Analyzer (07827)
    Chiron Diagnostics 550 Express (10352)
ANALYTE: Microprotein, CSF (4026)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Microprotein, Urine (4027)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Myoglobin (4023)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Roche Cobas INTEGRA (55179)
    Technicon Immuno 1 System (61042)
ANALYTE: Nitrite, Urine (4318)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
ANALYTE: Osmolality, Serum (4602)

TEST SYSTEM, ASSAY, EXAMINATION:

    Advanced Instruments Micro Osmometer Model 3300 (04671)
ANALYTE: Osmolality, Urine (4603)

TEST SYSTEM, ASSAY, EXAMINATION:

    Advanced Instruments Micro Osmometer Model 3300 (04671)
ANALYTE: Oxyhemoglobin/Oxygen Saturation (4604)

TEST SYSTEM, ASSAY, EXAMINATION:

    A-VOX Systems AVOXimeter 4000 (04678)
    Chiron Diagnostics 2500 CO-oximeter (10346)
    Chiron Diagnostics 270 CO-oximeter (10347)
    Chiron Diagnostics 845 (10370)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 865 (10374)
    Instrumentation Laboratory IL Synthesis (28466)
ANALYTE: Phenylalanine (4942)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad RADIAS System (07493)
ANALYTE: Phosphorus (4906)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Potassium (4910)

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL 9180 (04664)
    Chiron Diagnostics 288 (10350)
    Chiron Diagnostics 348 System (10337)
    Chiron Diagnostics 400 System (10338)
    Chiron Diagnostics 480 (10351)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Chiron Diagnostics 614 (10364)
    Chiron Diagnostics 644 (10366)
    Chiron Diagnostics 654 (10367)
    Chiron Diagnostics 664 FAST 4 (10368)
    Chiron Diagnostics 850 (10371)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 860 (10373)
    Chiron Diagnostics 865 (10374)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Instrumentation Laboratory IL Synthesis (28466)
    Mallinckrodt Gem Premier Plus (40254)
    Medica EasyStat Na/K/Li Analyzer (40256)
ANALYTE: Prealbumin (4911)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Prostatic Specific Antigen (PSA) (4919)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star with aca plus Immunoassay System (13424)

[[Page 17389]]

    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)
ANALYTE: Protein Fractions (4920)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Paragon CZE 2000 (07725)
ANALYTE: Protein, Total (4921)
TEST SYSTEM, ASSAY, EXAMINATION:
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Protein, Total (urine) (4972)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
    Boehringer Mannheim Hitachi 747/STC AutoLite (07785)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Pseudocholinesterase (4923)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Reduced Hemoglobin (Deoxyhemoglobin) (5523)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 845 (10370)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 865 (10374)
    Instrumentation Laboratory IL Synthesis (28466)
ANALYTE: Sodium (5805)

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL 9180 (04664)
    Chiron Diagnostics 288 (10350)
    Chiron Diagnostics 348 System (10337)
    Chiron Diagnostics 400 System (10338)
    Chiron Diagnostics 480 (10351)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Chiron Diagnostics 614 (10364)
    Chiron Diagnostics 644 (10366)
    Chiron Diagnostics 654 (10367)
    Chiron Diagnostics 664 FAST 4 (10368)
    Chiron Diagnostics 850 (10371)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 860 (10373)
    Chiron Diagnostics 865 (10374)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Instrumentation Laboratory IL Synthesis (28466)
    Mallinckrodt Gem Premier Plus (40254)
    Medica EasyStat Na/K/Li Analyzer (40256)
ANALYTE: Sorbital Dehydrogenase (SDH) (5823)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Transferrin (6114)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman IMMAGE Immunochemistry System (07816)
    Chiron Diagnostics 550 Express (10352)
ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Troponin T (Tn T) (6140)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
ANALYTE: Urea (BUN) (6403)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Uric Acid (6404)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Bichromatic ABA 200 (04036)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Urobilinogen, Urine (6413)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
ANALYTE: Vitamin B12 (6707)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
ANALYTE: pH, Urine (4978)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
SPECIALITY/SUBSPECIALITY: General Immunology
ANALYTE: Allergen specific IgE (0417)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pharmacia UniCAP 100 (49164)
ANALYTE: Alpha-1-Antitrypsin (0421)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Beta-2 microglobulin (0703)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring Nephelometer (07273)
    Behring Nephelometer 100 (07272)

[[Page 17840]]

    Behring Nephelometer II (07563)
    Dade aca Star (13423)
    Roche Cobas Bio with DENS (automated data reduction) (55208)
    Roche Cobas FARA (55040)
    Roche Cobas Mira (55044)
ANALYTE: C-Reactive Protein (CRP) (1001)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman IMMAGE Immunochemistry System (07816)
    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: C1-Esterase Inhibitor (C1INH) (1051)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring Nephelometer (07273)
    Behring Nephelometer 100 (07272)
    Behring Nephelometer II (07563)
ANALYTE: CD4 positive Lymphocytes (1116)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter STKS (10093)
ANALYTE: CD8 positive Lymphocytes (1118)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter STKS (10093)
ANALYTE: Complement C3 (1029)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
ANALYTE: Complement C4 (1030)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
ANALYTE: Cytomegalovirus Antibodies (1039)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott AxSYM CMV IgG (04628)
    Cirrus Diagnostics Immulite (10159)
    Quest SeraQuest CMV IgG/Hyperion HyPrep Plus (auto. calc.) (52048)
    Sienna Biotech Copalis One Immunoassay Sys/CMV Total Ab (58418)
    Sienna Biotech Copalis One Immunoassay Sys/ToRC Total Ab (58415)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Helicobacter pylori Antibodies (2513)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott FlexPack HP Test (04673)
ANALYTE: Herpes simplex I and/or II Antibodies (2530)

TEST SYSTEM, ASSAY, EXAMINATION:

    Cirrus Diagnostics Immulite (10159)
ANALYTE: Immunoglobulins--monoclonal/polyclonal (2802)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Paragon CZE 2000 (07725)
ANALYTE: Immunoglobulins IgA (2803)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336) bioMerieux Vitek VIDAS (07806)
ANALYTE: Immunoglobulins IgG (2806)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
ANALYTE: Immunoglobulins IgM (2808)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
ANALYTE: Lyme Disease Antibodies (Borrelia burgdorferi Abs) (3714)

TEST SYSTEM, ASSAY, EXAMINATION:

    Remel Rapidot Lyme Disease (B. burgdorferi IgG/IgM Abs) (55219)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY, EXAMINATION:

    bioMerieux Vitek VIDAS (07806)
ANALYTE: Mycoplasma pneumoniae Antibodies (4016)

TEST SYSTEM, ASSAY, EXAMINATION:

    Remel Mycoplasma pneumonia IgG/IgM (55214)
ANALYTE: Rheumatoid Factor (RF) (5508)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman IMMAGE Immunochemistry System (07816)
    Randox Laboratories RF Latex Test (55209)
    Roche Cobas INTEGRA (55179)
ANALYTE: Rubella Antibodies (5510)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott AxSYM Rubella IgG (04629)
    Behring OPUS (07793)
    Murex Rub-ex Latex Agglutination (40243)
    Quest SeraQuest Rubella IgG/Hyperion HyPrep Plus (auto calc) 
(52039)
    Sienna Biotech Copalis One Immunoassay Sys/Rubella Total Ab (58417)
    Sienna Biotech Copalis One Immunoassay Sys/ToRC Total Ab (58415)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Rubeola Antibodies (measles) (5511)

TEST SYSTEM, ASSAY, EXAMINATION:

    bioMerieux Vitek VIDAS (07806)
ANALYTE: Toxoplasma gondii Antibodies (6113)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott AxSYM Toxo IgG (04645)
    Abbott AxSYM Toxo IgM (04640)
    Behring OPUS (07793)
    Quest SeraQuest Toxo IgG/Hyperion HyPrep Plus (auto calc) (52045)
    Sienna Biotech Copalis One Immunoassay Sys/ToRC Total Ab (58415)
    Sienna Biotech Copalis One Immunoassay Sys/Toxo Total Ab

[[Page 17841]]

      (58416)
    Technicon Immuno 1 System (61042) bioMerieux Vitek VIDAS (07806)
ANALYTE: Troponin-I (Cardiac) (6153)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
ANALYTE: Varicella-Zoster Virus Antibodies (6704)

TEST SYSTEM, ASSAY, EXAMINATION:

    bioMerieux Vitek VIDAS (07806)
SPECIALITY/SUBSPECIALITY: Hematology
ANALYTE: Activated Clotting Time (ACT) (0461)

TEST SYSTEM, ASSAY, EXAMINATION:

    International Technidyne Hemochron Jr. Low Range ACT (28464)
ANALYTE: Activated Partial Thromboplastin Time (APTT) (0409)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
    Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) (58413)
    Sigma Diagnostics Amelung KC 1 A Coagulation Analyzer (58411)
    Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer (58412)
ANALYTE: Antithrombin III (ATIII) (0456)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
    Roche Cobas INTEGRA (55179)
ANALYTE: Fibrin Split Products (Fibrin Degradation) (1904)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
    Instrumentation Laboratory IL ACL 6000 (28454)
    Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) (58413)
    Sigma Diagnostics Amelung AMAX CS-190 (manual dilution) (58414)
ANALYTE: Hematocrit (2514)

TEST SYSTEM, ASSAY, EXAMINATION:

    Array Medical Ichor (04670)
    Becton Dickinson QBC AUTOREAD System with QBC AccuTube (07784)
    Chiron Diagnostics 348 System (10337)
    Chiron Diagnostics 400 System (10338)
    Coulter GEN-S System (10381)
    Danam EXCELL 16 (13430)
    Infolab EXCELL 16 (28457)
    Instrumentation Laboratory IL Synthesis (28466)
    Mallinckrodt Gem Premier Plus (40254)
    Swelab Instrument AB AutoCounter (58402)
ANALYTE: Hemoglobin (2515)

TEST SYSTEM, ASSAY, EXAMINATION:

    A-VOX Systems AVOXimeter 4000 (04678)
    Array Medical Ichor (04670)
    Becton Dickinson QBC AUTOREAD System with QBC AccuTube (07784)
    Chiron Diagnostics 280 (10349)
    Chiron Diagnostics 288 (10350)
    Chiron Diagnostics 845 (10370)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 865 (10374)
    Coulter GEN-S System (10381)
    Danam EXCELL 16 (13430)
    Infolab EXCELL 16 (28457)
    Instrumentation Laboratory IL Synthesis (28466)
    Swelab Instrument AB AutoCounter (58402)
    Technicon opeRA (61161)
ANALYTE: Heparin (2518)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Plasminogen (4907)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Platelet Activated Clot Ratio (4977)

TEST SYSTEM, ASSAY, EXAMINATION:

    HemoTec Hepcon/HMS (Platelet Function Test-PAF) (25260)
ANALYTE: Platelet Aggregation (4928)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chrono-log Whole Blood Aggregometer (10339)
ANALYTE: Platelet Count (4908)

TEST SYSTEM, ASSAY, EXAMINATION:

    Array Medical Ichor (04670)
    Becton Dickinson QBC AUTOREAD System with QBC AccuTube (07784)
    Coulter GEN-S System (10381)
    Danam EXCELL 16 (13430)
    Infolab EXCELL 16 (28457)
    Swelab Instrument AB AutoCounter (58402)
ANALYTE: Prothrombin Time (PT) (4922)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
    Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) (58413)
    Sigma Diagnostics Amelung KC 1 A Coagulation Analyzer (58411)
    Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer (58412)
ANALYTE: Red Blood Cell Count (Erythrocyte Count) (RBC) (5502)

TEST SYSTEM, ASSAY, EXAMINATION:

    Array Medical Ichor (04670)
    Coulter GEN-S System (10381)
    Danam EXCELL 16 (13430)
    Infolab EXCELL 16 (28457)
    Swelab Instrument AB AutoCounter (58402)
ANALYTE: Reptilase Time (5521)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring Coagulation Timer (BCT) (07824)
    Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) (58413)
    Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer (58412)
ANALYTE: Reticulocyte Count (5506)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter GEN-S System (10381)
    IMI MICRO21 with Retic (28448)
ANALYTE: Thrombin Time (6105)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) (58413)
    Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer (58412)
ANALYTE: White Blood Cell Count (Leukocyte Count) (WBC) (7002)

[[Page 17842]]

TEST SYSTEM, ASSAY, EXAMINATION:

    Array Medical Ichor (04670)
    Becton Dickinson QBC AUTOREAD System with QBC AccuTube (07784)
    Coulter GEN-S System (10381)
    Danam EXCELL 16 (13430)
    Infolab EXCELL 16 (28457)
    Swelab Instrument AB AutoCounter (58402)
ANALYTE: White Blood Cell Differential (WBC Diff) (7001)

TEST SYSTEM, ASSAY, EXAMINATION:

    Becton Dickinson QBC AUTOREAD System with QBC AccuTube (07784)
    Coulter GEN-S System (10381)
    Danam EXCELL 16 (13430)
    IMI MICRO21 (no interpret. atypical/immature cells) (28446)
    Infolab EXCELL 16 (28457)
    Swelab Instrument AB AutoCounter (58402)
SPECIALITY/SUBSPECIALITY: Toxicology / TDM
ANALYTE: Acetaminophen (0406)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 737 (07165)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)
    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Du Pont Dimension (13086)
    Du Pont Dimension AR (13087)
    Du Pont Dimension ES (13215)
    Du Pont Dimension XL (13355)
    Olympus AU 5000 (46001)
    Olympus AU 5200 (46143)
    Technicon RA XT (61013)
ANALYTE: Amikacin (0425)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Amphetamines (0428)

TEST SYSTEM, ASSAY, EXAMINATION:

    Applied Biotech SureStep Drug Screen AMP Test (04674)
    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)
ANALYTE: Barbiturates (0701)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Ciba Corning 550 Express (10038)
    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Benzodiazepines (0702)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Cannabinoids (THC) (1009)

TEST SYSTEM, ASSAY, EXAMINATION:

    Applied Biotech SureStep Drug Screen THC Test (04675)
    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    TCPI One-Step Urine DOA Cannabinoid (THC) (61258)
ANALYTE: Carbamazepine (1010)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Du Pont Dimension (13086)
    Du Pont Dimension AR (13087)
    Du Pont Dimension ES (13215)
    Du Pont Dimension XL (13355)
ANALYTE: Carboxyhemoglobin (1012)

TEST SYSTEM, ASSAY, EXAMINATION:

    A-VOX Systems AVOXimeter 4000 (04678)
    Chiron Diagnostics 2500 CO-oximeter (10346)
    Chiron Diagnostics 270 CO-oximeter (10347)
    Chiron Diagnostics 845 (10370)
    Chiron Diagnostics 855 (10372)
    Chiron Diagnostics 865 (10374)
    Instrumentation Laboratory IL Synthesis (28466)
ANALYTE: Cocaine Metabolites (1023)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Digitoxin (1303)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Digoxin (1304)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman IMMAGE Immunochemistry System (07816)
    Behring OPUS (07793)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (DGN A) (13426)
    Dade aca Star (manual pretreatment) (13427)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Ethanol (Alcohol) (1608)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Technicon AXON (61001)
ANALYTE: Ethosuximide (1609)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Gentamicin (2202)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Du Pont Dimension AR (13087)
    Du Pont Dimension ES (13215)
    Du Pont Dimension XL (13355)
ANALYTE: Lidocaine (3710)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Lithium (3712)

[[Page 17843]]

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL 9180 (04664)
    Chiron Diagnostics 480 (10351)
    Chiron Diagnostics 654 (10367)
    Medica EasyStat Na/K/Li Analyzer (40256)
ANALYTE: Lysergic Acid Diethylamide (LSD) (3715)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717 (07163)
ANALYTE: Methadone (4003)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Methamphetamines (4004)

TEST SYSTEM, ASSAY, EXAMINATION:

    Applied Biotech SureStep Drug Screen Methamphetamine Test (04669)
    Chiron Diagnostics 550 Express (10352)
ANALYTE: Methotrexate (4006)

TEST SYSTEM, ASSAY,EXAMINATION:

    Dade aca Star (13423)
    ANALYTE: Morphine (4020)

TEST SYSTEM, ASSAY, EXAMINATION:

    Applied Biotech SureStep Drug Screen MOR Test (04676)
ANALYTE: N-Acetylprocainamide (NAPA) (4301)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
ANALYTE: Opiates (4601)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Phencyclidine (PCP) (4901)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Dimension AR (13421)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Phenobarbital (4902)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Phenytoin (4903)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Primidone (4912)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 737 (07165)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)
    Dade aca Star (13423)
    Olympus AU 5000 (46001)
    Olympus AU 5200 (46143)
ANALYTE: Procainamide (4913)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 5 CE (07491)
    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Boehringer Mannheim Hitachi 737 (07165)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)
    Chiron Diagnostics 550 Express (10352)
    Dade aca Star (13423)
    Olympus AU 5000 (46001)
    Olympus AU 5200 (46143)
    Olympus AU 800 (46110)
    Olympus Reply (46089)
ANALYTE: Quinidine (5202)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade aca Star (13423)
ANALYTE: Salicylates (5801)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Theophylline (6104)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade Analyst (13425)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Tobramycin (6112)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Du Pont Dimension AR (13087)
    Du Pont Dimension ES (13215)
    Du Pont Dimension XL (13355)
ANALYTE: Tricyclic Antidepressants (6117)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 4 (07071)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 (07072)
    Beckman Synchron CX 5 CE (07491)
    Beckman Synchron CX 7 (07073)
    Boehringer Mannheim Hitachi 717 (07163)
    Boehringer Mannheim Hitachi 737 (07165)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)
    Dade aca Star (13423)
    Olympus AU 5000 (46001)
    Olympus AU 5200 (46143)
    Olympus AU 800 (46110)
    Olympus Reply (46089)
    Roche Cobas FARA (55040)
ANALYTE: Valproic Acid (6701)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 4 Delta (07762)
    Beckman Synchron CX 5 CE (07491)
    Beckman Synchron CX 5 Delta (07763)
    Beckman Synchron CX 7 Delta (07764)

[[Page 17844]]

    Behring OPUS (07793)
    Boehringer Mannheim Hitachi 737 (07165)
    Boehringer Mannheim Hitachi 747 (07166)
    Dade aca Star (13423)
    Olympus AU 5000 (46001)
    Olympus AU 5200 (46143)
    Olympus AU 800 (46110)
    Olympus Reply (46089)
ANALYTE: Vancomycin (6703)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
    Du Pont Dimension (13086)
    Du Pont Dimension AR (13087)
    Du Pont Dimension ES (13215)
    Du Pont Dimension XL (13355)
SPECIALITY/SUBSPECIALITY: Urinalysis
ANALYTE: Hemoglobin, Urine (2564)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
    Boehringer Mannheim Hitachi 747 (STC Auto-Lyte) (07767)
    Roche Cobas Bio (STC Auto-Lyte) (55200)
ANALYTE: Leukocyte Esterase, Urinary (3757)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
    Boehringer Mannheim Hitachi 747 (STC Auto-Lyte) (07767)
    Roche Cobas Bio (STC Auto-Lyte) (55200)
ANALYTE: Total Solids (Specific Gravity) (6125)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 4 CE/DRI Gravity-Detect (07802)
    Beckman Synchron CX 4/DRI Gravity-Detect (07801)
    Beckman Synchron CX 5 CE/DRI Gravity-Detect (07804)
    Beckman Synchron CX 5/DRI Gravity-Detect (07803)
    Beckman Synchron CX 7/DRI Gravity-Detect (07805)
    Boehringer Mannheim Hitachi 704/DRI Gravity-Detect (07796)
    Boehringer Mannheim Hitachi 717/Chimera UA PERFECT (07780)
    Boehringer Mannheim Hitachi 717/DRI Gravity-Detect (07797)
    Boehringer Mannheim Hitachi 737/DRI Gravity-Detect (07798)
    Boehringer Mannheim Hitachi 747/DRI Gravity-Detect (07799)
    Boehringer Mannheim Hitachi 911/DRI Gravity-Detect (07800)
    Chiron Diagnostics 550 Express/DRI Gravity-Detect (10379)
    Ciba Corning 550 Express/DRI Gravity-Detect (10335)
    IRIS/BM 900UDx Urine Pathology System (28453)
    Instrumentation Laboratory IL Monarch 1000/DRI Grav-Det (28455)
    Instrumentation Laboratory IL Monarch 2000/DRI Grav-Det (28456)
    Olympus AU 5000/DRI Gravity-Detect (46218)
    Olympus AU 5200/DRI Gravity-Detect (46219)
    Olympus AU 800/DRI Gravity-Detect (46220)
    Olympus Reply/DRI Gravity-Detect (46221)
    Roche Cobas FARA/DRI Gravity-Detect (55211)
    Roche Cobas Mira/DRI Gravity-Detect (55210)
ANALYTE: Urinary Sediment Microscopic Elements (6405)

TEST SYSTEM, ASSAY, EXAMINATION:

    IRIS/BM 900UDx Urine Pathology System (28453)
    Sysmex UF-100 (58410)
ANALYTE: Urine Qualitative Dipstick Chemistries (6406)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer CLINITEK 50 Urine Chemistry Analyzer (07788)
    IRIS/BM 900UDx Urine Pathology System (28453)
SPECIALITY/SUBSPECIALITY: Virology
ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY, EXAMINATION:

    bioMerieux Vitek VIDAS (07806)
COMPLEXITY: HIGH
SPECIALITY/SUBSPECIALITY: Bacteriology
ANALYTE: Aerobic &/or Anaerobic Organisms-unlimited sources (0412)

TEST SYSTEM, ASSAY, EXAMINATION:

    Becton Dickinson BBL CRYSTAL N/H ID Sys. (inc. culture) (07807)
ANALYTE: Chlamydia (1016)

TEST SYSTEM, ASSAY, EXAMINATION:

    Vitek Systems VIDAS Chlamydia Blocking Assay (67102)
    bioMerieux Vitek VIDAS (07806)
    bioMerieux Vitek VIDAS Chlamydia Blocking Assay (07825)
ANALYTE: Staphylococcus (5807)

TEST SYSTEM, ASSAY, EXAMINATION:

    Remel Staph Latex Kit (inc. culture) (55215)
SPECIALITY/SUBSPECIALITY: Endocrinology
ANALYTE: 25-Hydroxyvitamin D (25-OH-D) (0110)

TEST SYSTEM, ASSAY, EXAMINATION:

    Incstar 25-Hydroxyvitamin D 125I RIA Kit (28374)
ANALYTE: Androstenedione (0460)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostic Systems DSL-10-3800 ACTIVE Androstenedione EIA (13429)
ANALYTE: Catecholamines, Plasma (1056)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CDM System/Bio-Rad HPLC (07792)
ANALYTE: Cortisol, Urine (extraction procedure) (1095)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Ciba Corning ACS 180 Plus (10336)
    bioMerieux Vitek VIDAS (07806)
ANALYTE: Dehydroepiandrosterone Sulfate (DHEA-SO4) (1310)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostic Systems DSL-C2700 DHEA-S-7 RIA (13433)
ANALYTE: Estriol-unconjugated (1607)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostic Systems DSL-10-3700 ACTIVE Unconj. Estriol EIA (13434)
ANALYTE: Follicle Stimulating Hormone (FSH) (1908)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostic Systems DSL-4700 ACTIVE FSH IRMA (13432)
ANALYTE: Gastrin (2205)

[[Page 17845]]

TEST SYSTEM, ASSAY, EXAMINATION:

    Biosyn Gastrin EIA (07786)
    ICN Gastrin EIA (28444)
ANALYTE: HCG, Total, Serum, Quantitative (2555)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostic Systems DSL-10-8300 ACTIVE Intact hCG ELISA (13428)
ANALYTE: Homovanillic Acid (HVA) (2545)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CDM System/Bio-Rad HPLC (07792)
ANALYTE: Insulin (2812)

TEST SYSTEM, ASSAY, EXAMINATION:

    ALPCO Mercodia Insulin Enzyme Immunoassay (ELISA) (04679)
ANALYTE: Insulin-like Growth Factor-II (IGF-II) (2834)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostic Systems DSL-9100 ACTIVE IGF-II IRMA (13431)
ANALYTE: Metanephrines, Urine (4025)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CDM System/Bio-Rad HPLC (07792)
ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY, EXAMINATION:

    United Biotech UBI MAGIWEL T4 (Thyroxine) Quantitative (64034)
ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY, EXAMINATION:

    United Biotech UBI MAGIWEL T3 (Triiodothyronine) Quant. (64035)
ANALYTE: Vanillylmandelic Acid (VMA) (6710)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CDM System/Bio-Rad HPLC (07792)
SPECIALITY/SUBSPECIALITY: General Chemistry
ANALYTE: Alkaline Phosphatase (ALP) (0416)

TEST SYSTEM, ASSAY, EXAMINATION:

    HiChem Alkaline Phosphatase Reagent Kit (manual) (25262)
ANALYTE: Alkaline Phosphatase Bone Specific (BAP) (0518)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hybritech Tandem-R Ostase (25170)
ANALYTE: Blood Gases with pH (0708)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 158 (10340)
    Chiron Diagnostics 168 (10341)
ANALYTE: Creatine Kinase (CK) (1034)

TEST SYSTEM, ASSAY, EXAMINATION:

    HiChem Creatine Kinase Reagent Kit (manual) (25263)
ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad MDMS (07781)
ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Chiron Diagnostics 570 Alliance (10359)
    Chiron Diagnostics 580 Alliance (10362)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Iron Binding Capacity (post saturation/separation) (2815)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
    Dade Dimension AR (13421)
    Dade Dimension ES (13420)
    Dade Dimension RxL (13436)
    Dade Dimension XL (13422)
    Dade aca Star (13423)
ANALYTE: Lipoprotein Fractions (3720)

TEST SYSTEM, ASSAY, EXAMINATION:

    Zaxis LFS Lipogel Assay Kit (79049)
ANALYTE: Oxalate (4605)

TEST SYSTEM, ASSAY, EXAMINATION:

    Chiron Diagnostics 550 Express (10352)
ANALYTE: Phenylalanine (4942)

TEST SYSTEM, ASSAY, EXAMINATION:

    Shield Diagnostics Quantase Phenylalanine (58425)
ANALYTE: Protein Fractions (4920)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sebia Hydragel 15/30 Protein (E) Kit (for HYDRASYS) (58393)
    Sebia Hydragel IF//IF Penta (for HYDRASYS) (58399)
    Sebia Hydragel IF/Double IF/IF Penta (manual) (58398)
ANALYTE: Retinol binding protein (5507)

TEST SYSTEM, ASSAY, EXAMINATION:

    The Binding Site Human Retinol Binding Protein 'NL' NANORID (61253)
ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY, EXAMINATION:

    Horizon Diagnostics Triglycerides-GPO Reagent (manual) (25167)
ANALYTE: Vitamin B6 (6718)

TEST SYSTEM, ASSAY, EXAMINATION:

    ALPCO Vitamin B6 3H REA (04667)
SPECIALITY/SUBSPECIALITY: General Immunology
ANALYTE: Anti-Cardiolipin Antibodies (0434)

TEST SYSTEM, ASSAY, EXAMINATION:

    ALPCO ORGenTec Anti-Cardiolipin (IgA) ELISA (04672)
    ALPCO ORGenTec Anti-Cardiolipin (IgG/IgM) ELISA (04668)
    Shield Diagnostics DIASTAT anti-Cardiolipin IgG/IgM (qual) (58422)
    Shield Diagnostics DIASTAT anti-Cardiolipin IgG/IgM (quant) (58421)
ANALYTE: Anti-Centromere Antibodies (0487)

TEST SYSTEM, ASSAY, EXAMINATION:

    Shield Diagnostics DIASTAT Anti-Centromere Kit (qual) (58423)
    Shield Diagnostics DIASTAT Anti-Centromere Kit (semi-quant) (58312)
ANALYTE: Anti-DNA Antibodies (0435)

TEST SYSTEM, ASSAY, EXAMINATION:

    TheraTest Laborat EL-ANA/6(ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) (61235)
    TheraTest Laboratories EL-ANA Profiles (anti-dsDNA) (61243)
    TheraTest Laboratories EL-ANA Profiles (anti-ssDNA) (61242)
    TheraTest Laboratories EL-ANA Profiles (anti-ssDNA, -dsDNA) (61239)
    TheraTest Labs EL-ANA/7H(ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) (61236)
    TheraTest Labs EL-ANA/7S(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) (61237)

[[Page 17846]]

    TheraTest Labs EL-ANA/8(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) (61238)
ANALYTE: Anti-ENA Antibodies (0507)

TEST SYSTEM, ASSAY, EXAMINATION:

    INOVA Diag QUANTALite ENA6 ELISA/Sm,RNP,SSA,SSB,Scl-70,Jo-1 (28465)
    Immuno Concepts RELISA Sng Well/RNP,Sm,SS-A,SS-B,Scl-70,Jo1 (28467)
ANALYTE: Anti-Glomerular Basement Membrane (GBM) Antibodies (0524)

TEST SYSTEM, ASSAY, EXAMINATION:

    Shield Diagnostics DIASTAT anti-GBM (qual) (58427)
    Shield Diagnostics DIASTAT anti-GBM (semi-quant) (58426)
ANALYTE: Anti-Histone Antibodies (0437)

TEST SYSTEM, ASSAY, EXAMINATION:

    TheraTest Laboratories EL-ANA Profiles (anti-Histone) (61249)
    TheraTest Labs EL-ANA/7H(ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) (61236)
    TheraTest Labs EL-ANA/8(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) (61238)
ANALYTE: Anti-Jo-1 (0438)

TEST SYSTEM, ASSAY, EXAMINATION:

    Immuno Concepts RELISA Jo-1 (28449)
    TheraTest Laboratories EL-ANA Profiles (anti-Jo-1) (61250)
ANALYTE: Anti-Mitochondrial Antibodies (AMTA) (0439)

TEST SYSTEM, ASSAY, EXAMINATION:

    The Binding Site Rat Liver, Kidney, Stomach IFA Kit (61254)
ANALYTE: Anti-Myeloperoxidase (MPO) Antibodies (0505)

TEST SYSTEM, ASSAY, EXAMINATION:

    Wampole MPO IgG,A,M ELISA (70191)
ANALYTE: Anti-Neutrophil Cytoplasm Antibodies (0440)

TEST SYSTEM, ASSAY, EXAMINATION:

    INOVA Diagnostics NOVA Lite ANCA (28463)
    Scimedx Anti-Neutrophil Cytoplasmic Ab (ANCA) (IFA) (58419)
ANALYTE: Anti-Nuclear Antibodies (ANA) (0441)

TEST SYSTEM, ASSAY, EXAMINATION:

    IMI MICRO21/Immuno Concepts Colorzyme ANA (28447)
    The Binding Site Rat Liver, Kidney, Stomach IFA Kit (61254)
ANALYTE: Anti-Parietal Cell Antibodies (0442)

TEST SYSTEM, ASSAY, EXAMINATION:

    The Binding Site Rat Liver, Kidney, Stomach IFA Kit (61254)
ANALYTE: Anti-Proteinase-3 (PR-3) Antibodies (0525)

TEST SYSTEM, ASSAY, EXAMINATION:

    Shield Diagnostics DIASTAT Anti-PR3 (cANCA) (qual) (58424)
    Shield Diagnostics DIASTAT Anti-PR3 (cANCA) (semi-quant) (58329)
    Wampole PR-3 IgG,A,M ELISA (70190)
ANALYTE: Anti-RNP (Ribonucleoprotein) (0443)

TEST SYSTEM, ASSAY, EXAMINATION:

    TheraTest Laboratories EL-ANA Profiles (anti-Sm, -RNP) (61240)
ANALYTE: Anti-RNP-Sm Antibodies (0502)

TEST SYSTEM, ASSAY, EXAMINATION:

    Immuno Concepts RELISA Sm/RNP (28451)
    TheraTest Laborat EL-ANA/6(ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) (61235)
    TheraTest Laboratories EL-ANA Profiles (anti-RNP/Sm) (61245)
    TheraTest Labs EL-ANA/7H(ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) (61236)
    TheraTest Labs EL-ANA/7S(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) (61237)
    TheraTest Labs EL-ANA/8(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) (61238)
ANALYTE: Anti-Ribosomal P Antibodies (0445)

TEST SYSTEM, ASSAY, EXAMINATION:

    Immuno Probe Ribosomal P EIA Test (28441)
ANALYTE: Anti-SS-A/Ro (0446)

TEST SYSTEM, ASSAY, EXAMINATION:

    Immuno Concepts RELISA SS-A/Ro--SS-B/LA (28450)
    TheraTest Laborat EL-ANA/6(ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) (61235)
    TheraTest Laboratories EL-ANA Profiles (anti-SS-A) (61246)
    TheraTest Laboratories EL-ANA Profiles (anti-SS-A, -SS-B) (61241)
    TheraTest Labs EL-ANA/7H(ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) (61236)
    TheraTest Labs EL-ANA/7S(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) (61237)
    TheraTest Labs EL-ANA/8(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) (61238)
ANALYTE: Anti-SS-B/La (0447)

TEST SYSTEM, ASSAY, EXAMINATION:

    Immuno Concepts RELISA SS-A/Ro--SS-B/LA (28450)
    TheraTest Laborat EL-ANA/6(ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) (61235)
    TheraTest Laboratories EL-ANA Profiles (anti-SS-A, -SS-B) (61241)
    TheraTest Laboratories EL-ANA Profiles (anti-SS-B) (61247)
    TheraTest Labs EL-ANA/7H(ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) (61236)
    TheraTest Labs EL-ANA/7S(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) (61237)
    TheraTest Labs EL-ANA/8(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) (61238)
ANALYTE: Anti-Scl-70 (0448)

TEST SYSTEM, ASSAY, EXAMINATION:

    Immuno Concepts RELISA Scl-70 (28452)
    TheraTest Laboratories EL-ANA Profiles (anti-Scl-70) (61248)
    TheraTest Labs EL-ANA/7S(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) (61237)
    TheraTest Labs EL-ANA/8(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl70,H) (61238)
ANALYTE: Anti-Sm (Smith) (0450)

TEST SYSTEM, ASSAY, EXAMINATION:

    Immuno Concepts RELISA Sm/RNP (28451)
    TheraTest Laborat EL-ANA/6(ssDNA,dsDNA,Sm,RNP/Sm,SS-A,SS-B) (61235)
    TheraTest Laboratories EL-ANA Profiles (anti-Sm) (61244)
    TheraTest Laboratories EL-ANA Profiles (anti-Sm, -RNP) (61240)
    TheraTest Labs EL-ANA/7H(ssDNA,dsDNA,Sm,RNP/Sm,SSA,SSB,His) (61236)
    TheraTest Labs EL-ANA/7S(ss&dsDNA,Sm,RNP/Sm,SSA,SSB,Scl-70) (61237)
    TheraTest Labs EL-ANA/8(ss&dsDNA,Sm,RNP/

[[Page 17847]]

      Sm,SSA,SSB,Scl70,H) (61238)
ANALYTE: Anti-Smooth Muscle Antibodies (ASMA) (0451)

TEST SYSTEM, ASSAY, EXAMINATION:

    The Binding Site Rat Liver, Kidney, Stomach IFA Kit (61254)
ANALYTE: Anti-Thyroglobulin Antibodies (0453)

TEST SYSTEM, ASSAY, EXAMINATION:

    IMMCO Diagnostics ImmuLisa Anti-Thyroglobulin (Tg) Ab ELISA (28443)
ANALYTE: Beta-2 microglobulin (0703)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Cobas Bio without DENS (manual data reduction) (55207)
ANALYTE: Cytomegalovirus Antibodies (1039)

TEST SYSTEM, ASSAY, EXAMINATION:

    Incstar CMV IgG ``fast'' ELISA (28461)
    Incstar CMV IgG ELISA (28460)
    Incstar CMV IgM Capture ELISA (28462)
    Quest SeraQuest CMV IgG (manual/qual.) (52046)
    Quest SeraQuest CMV IgG/Hyperion HyPrep Plus (man. calc.) (52047)
ANALYTE: Entamoeba histolytica Antibodies (1601)

TEST SYSTEM, ASSAY, EXAMINATION:

    Trend Scientific TREND Amebiasis (E. histolytica) (spectro) (61231)
    Trend Scientific TREND Amebiasis (E. histolytica) (visual) (61232)
ANALYTE: Helicobacter pylori Antibodies (2513)

TEST SYSTEM, ASSAY, EXAMINATION:

    elias usa Varelisa Helicobacter pyl. Abs (IgG) (16112)
ANALYTE: Herpes simplex I and/or II Antibodies (2530)

TEST SYSTEM, ASSAY, EXAMINATION:

    Incstar HSV I/II IgG ``fast'' ELISA (28458)
    Incstar HSV I/II IgG ELISA (28459)
ANALYTE: Lyme Disease Antibodies (Borrelia burgdorferi Abs) (3714)

TEST SYSTEM, ASSAY, EXAMINATION:

    MarDx Lyme Disease (IgG) Marblot Strip Test System (40206)
    MarDx Lyme Disease (IgM) Marblot Strip Test System (40210)
ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY, EXAMINATION:

    Zeus Mumps IgG ELISA (79051)
ANALYTE: Rheumatoid Factor (RF) (5508)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hemagen Rheumatoid Factor Kit (EIA) (25261)
    Zeus Rheumatoid Factor (RF) IgM ELISA (79052)
ANALYTE: Rubella Antibodies (5510)

TEST SYSTEM, ASSAY, EXAMINATION:

    Quest SeraQuest Rubella IgG (manual/qual.) (52040)
    Quest SeraQuest Rubella IgG (manual/semi-quant.) (52041)
    Quest SeraQuest Rubella IgG/Hyperion HyPrep Plus (man. calc) 
(52038)
ANALYTE: Thyroid Peroxidase Autoantibodies (TPO) (6135)

TEST SYSTEM, ASSAY, EXAMINATION:

    IMMCO Diagnostics ImmuLisa Anti-Thyroid Peroxidase (TPO) Ab (28442)
ANALYTE: Toxoplasma gondii Antibodies (6113)

TEST SYSTEM, ASSAY, EXAMINATION:

    Quest SeraQuest Toxo IgG (manual/qual.) (52042)
    Quest SeraQuest Toxo IgG (manual/semi-quant.) (52043)
    Quest SeraQuest Toxo IgG/Hyperion HyPrep Plus (man. calc.) (52044)
ANALYTE: Varicella-Zoster Virus Antibodies (6704)

TEST SYSTEM, ASSAY, EXAMINATION:

    Zeus Varicella-Zoster IgG ELISA (79050)
    SPECIALITY/SUBSPECIALITY: Hematology
ANALYTE: Alpha-2-Antiplasmin (0463)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
ANALYTE: Antithrombin III (ATIII) (0456)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
    Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) (58413)
    Sigma Diagnostics Amelung AMAX CS-190 (manual dilution) (58414)
ANALYTE: Coagulation Factors (1044)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
    Sigma Diagnostics Amelung AMAX CS-190 (auto dilution) (58413)
    Sigma Diagnostics Amelung AMAX CS-190 (manual dilution) (58414)
    Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer (58412)
ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sigma Diagnostics Amelung KC 1 A Coagulation Analyzer (58411)
    Sigma Diagnostics Amelung KC 4 A Micro Coagulation Analyzer (58412)
ANALYTE: Heparin (2518)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
ANALYTE: Heparin, Low Molecular Weight (LMWH) (2558)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
ANALYTE: Plasminogen (4907)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
ANALYTE: Plasminogen Activator Inhibitor (PAI) (4936)

TEST SYSTEM, ASSAY, EXAMINATION:

    Biopool TintElize PAI-1 (07787)
ANALYTE: Platelet Activated Clot Ratio (4977)

TEST SYSTEM, ASSAY, EXAMINATION:

    HemoTec Hepcon/HMS (Platelet

[[Page 17848]]

Function Test) (25243)
ANALYTE: Protein C (4929)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Behring Coagulation Timer (BCT) (07824)
    Instrumentation Laboratory IL ACL 6000 (28454)
ANALYTE: Protein S (4930)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA Compact Analyzer (04677)
    Instrumentation Laboratory IL ACL 6000 (28454)
ANALYTE: White Blood Cell Differential (WBC Diff) (7001)

TEST SYSTEM, ASSAY, EXAMINATION:

    IMI MICRO21 (with intrpret. atypical/immature cells) (28445)
SPECIALITY/SUBSPECIALITY: Mycobacteriology
ANALYTE: Mycobacteria (4024)

TEST SYSTEM, ASSAY, EXAMINATION:

    Becton Dickinson BBL MGIT/Mycobacteria Growth Indicator (07808)
    Organon Teknika MB/BacT Microbial Detection System (46215)
ANALYTE: Mycobacterium avium complex (4009)

TEST SYSTEM, ASSAY, EXAMINATION:

    Remel MycoAKT Culture ID M. avium complex (inc. cult.) (55217)
ANALYTE: Mycobacterium kansasii (4014)

TEST SYSTEM, ASSAY, EXAMINATION:

    Remel MycoAKT Culture ID M. kansasii (inc. cult.) (55218)
ANALYTE: Mycobacterium tuberculosis complex (4015)

TEST SYSTEM, ASSAY, EXAMINATION:

    Remel MycoAKT Culture ID M. tuberculosis cplx (inc. cult.) (55216)
SPECIALITY/SUBSPECIALITY: Parasitology
ANALYTE: Cryptosporidium (1109)

TEST SYSTEM, ASSAY, EXAMINATION:

    TechLab Crypto-Cel IF Test (61262)
    TechLab Crypto/Giardia-Cel IF Test (61263)
    Trend Scientific Crypto. parvum Dir Detect System (Spectro) (61252)
    Trend Scientific Crypto. parvum Dir Detect System (Visual) (61251)
ANALYTE: Entamoeba histolytica (1631)

TEST SYSTEM, ASSAY, EXAMINATION:

    TechLab E. histolytica Test (ELISA) (spectro) (61261)
    TechLab E. histolytica Test (ELISA) (visual) (61260)
ANALYTE: Giardia lamblia (2222)

TEST SYSTEM, ASSAY, EXAMINATION:

    TechLab Crypto/Giardia-Cel IF Test (61263)
SPECIALITY/SUBSPECIALITY: Toxicology / TDM
ANALYTE: Benzodiazepines (0702)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CDM System/Bio-Rad HPLC (07792)
ANALYTE: Tricyclic Antidepressants (6117)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CDM System/Bio-Rad HPLC (07792)
SPECIALITY/SUBSPECIALITY: Virology
ANALYTE: Cytomegalovirus (1038)

TEST SYSTEM, ASSAY, EXAMINATION:

    Du Pont Alliance CMV-Direct EA IFA (including cell culture) (13386)
    Light Diag. CMV Direct IFA (including cell culture) (37100)
ANALYTE: Herpes simplex (2529)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostic Hybrids ELVIS HSV GOLD (inc. cell culture) (13435)
ANALYTE: Influenza A (2828)

TEST SYSTEM, ASSAY, EXAMINATION:

    ZymeTx ViraZyme Culture Confirm. Screen (inc. cell culture) (79047)
ANALYTE: Influenza B (2829)

TEST SYSTEM, ASSAY, EXAMINATION:

    ZymeTx ViraZyme Culture Confirm. Screen (inc. cell culture) (79047)
ANALYTE: Parainfluenza 1 (4959)

TEST SYSTEM, ASSAY, EXAMINATION:

    ZymeTx ViraZyme Culture Confirm. Screen (inc. cell culture) (79047)
ANALYTE: Parainfluenza 2 (4960)

TEST SYSTEM, ASSAY, EXAMINATION:

    ZymeTx ViraZyme Culture Confirm. Screen (inc. cell culture) (79047)
ANALYTE: Parainfluenza 3 (4961)

TEST SYSTEM, ASSAY, EXAMINATION:

    ZymeTx ViraZyme Culture Confirm. Screen (inc. cell culture) (79047)
ANALYTE: Parainfluenza 4 (4975)

TEST SYSTEM, ASSAY, EXAMINATION:

    ZymeTx ViraZyme Culture Confirm. Screen (inc. cell culture) (79047)
ANALYTE: Respiratory syncytial virus (5503)

TEST SYSTEM, ASSAY, EXAMINATION:

    bioMerieux Vitek VIDAS (07806)
COMPLEXITY: WAIVED
SPECIALITY/SUBSPECIALITY: Endocrinology
ANALYTE: Ovulation Test (LH) by Visual Color Comparison (9461)

TEST SYSTEM, ASSAY, EXAMINATION:

    Vanguard Biomedical MiniClinic Ovulation Predictor (67100)
ANALYTE: Urine HCG by Visual Color Comparison Tests (9642)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bionike A/Q Pregnancy Test (07779)
    Chembio Sure Check Pregnancy Test (10334)
    CliniCare CliniStrip Urine Only Pregnancy (10383)
    CliniCare CliniStrip hCG Combo (10384)
    CliniCare CliniStrip hCG Pregnancy (10382)
    Genzyme Contrast Strip hCG (22185)
    Orion Diagnostica UniStep hCG II (46224)
    Vanguard Biomedical MiniStick Pregnancy Test (67101)
SPECIALITY/SUBSPECIALITY: General Chemistry
ANALYTE: Glucose Monitoring Devices (FDA Cleared/Home Use) (9221)

TEST SYSTEM, ASSAY, EXAMINATION:

    Boehringer Mannheim Accu-Chek Instant (07789)
    Boehringer Mannheim Accu-Chek Instant DM (07783)
    Boehringer Mannheim Accu-Chek InstantPlus (07782)
    Chematics CHEMCARD Glucose Test (10266)
    LXN Blood Glucose Testing System (37107)
    MediSense ExacTech RSG Blood Glucose System (40257)
SPECIALITY/SUBSPECIALITY: General Immunology

[[Page 17849]]

ANALYTE: Helicobacter pylori Antibodies (2513)

TEST SYSTEM, ASSAY, EXAMINATION:

    Quidel QuickVue One-Step H. pylori Test for Whole Blood (52037)
SPECIALITY/SUBSPECIALITY: Urinalysis
ANALYTE: Urine Dipstick or Tablet Analytes, nonautomated (9641)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer CHEK-STIX U.T.I. Test Strips (07790)
    Genesis Labs DIA SCREEN 10 Way Reagent Strips: Urinalysis (22182)
    TCPI URI-TEST Glucose in Urine (61256)
    TCPI URI-TEST Nitrite in Urine (61257)

[FR Doc. 97-9350 Filed 4-10-97; 8:45 am]
BILLING CODE 4163-18-P