17832 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

Dated: March 31, 1997.

G. Martin Wagner,

Associate Administrator, Office of

Governmentwide Policy.

Attachment

March 31, 1997.

[GSA Bulletin FTR 25]

To: Heads of Federal agencies.

Subject: Promoting, Encouraging, and

Facilitating the Use of Firesafe

Accommodations.

1. Purpose

This bulletin informs agencies that

pursuant to the Federal Travel Regulation

(FTR) (41 CFR 301–304) each agency is

responsible for influencing its employees

who require commercial lodging when

performing official travel to stay at an

approved firesafe accommodation. Further,

Federal employees traveling on official

business, and pre-employment interviewees,

are strongly encouraged to stay at an

approved accommodation as defined in FTR

§ 301–17.2(c).

2. Background

a. The Hotel and Motel Fire Safety Act of

1990, Pub. L. No. 101–391, 104 stat. 747

(codified as amended in scattered sections of

15 U.S.C. and 5 U.S.C.) (the Act) requires the

development and issuance of guidelines, and

sets standards, concerning the use and

installation of automatic sprinkler systems

and smoke detectors in places of public

accommodation affecting commerce.

b. In September 1994, the General Services

Administration (GSA) issued FTR

Amendment 39 (59 FR 46192, Sept. 7, 1994)

instructing agencies, among other things, to

ensure that each agency achieve an adequate

‘‘approved accommodations percentage’’ as

specified in the Act, and reflected in the FTR,

to enhance the safety of Federal employees

traveling on official business. An ‘‘approved

accommodations percentage’’ is the

percentage of nights that an agency’s

employees traveling on official business

spend in approved accommodations, i.e., any

place of public accommodation that meets

the requirements of the fire prevention and

control guidelines in 15 U.S.C. 2225, relative

to the total number of nights spent in places

of public accommodation.

c. Section 1614 of the National Defense

Authorization Act for Fiscal Year 1997, Pub.

L. No. 104–201, 110 Stat. 2739, repealed the

‘‘approved accommodations’’ data collection

and employee reporting requirement

imposed by the Act.

d. In December 1996, GSA issued FTR

Amendment 53 (61 FR 64997, Dec. 10, 1996)

to eliminate the ‘‘approved accommodations’’

data collection and reporting requirement.

e. GSA is issuing the guidelines contained

in this bulletin to inform agencies that

although the data collection and reporting

requirement was repealed, the provisions

that encourage agencies to promote the use

of ‘‘approved accommodations’’ or require,

with limited exception, the use of ‘‘approved

accommodations’’ for conferences were not

repealed. Agencies, therefore, should

continue to effectuate policies strongly

encouraging employees to use ‘‘approved

accommodations’’.

3. Hotel and Motel Fire Safety Guidelines

The Act sets standards for fire prevention

and control in places of public

accommodation affecting commerce. These

requirements include installation of hardwired, single station smoke detectors in each

guest room of each place of public

accommodation, and an automatic sprinkler

system in each place of public

accommodation that is more than three

stories. The Act further requires each State to

submit to the Director of the Federal

Emergency Management Agency (FEMA) a

list of places of public accommodation in the

State that comply with the Act’s fire safety

standards. From the State lists, FEMA must

compile and publish in the Federal Register

a national master list and distribute it to each

Federal agency. The Act requires FEMA to

periodically update the master list based on

information provided by the States, and to

distribute the updated list to each agency.

Any questions regarding the FEMA list may

be directed to Mr. John Ottoson, United

States Fire Administration, at (301) 447–

1272. The list is available via the internet at

http://www.usfa.fema.gov/hotel/hotelindex.

4. Federal Travel Program Compliance

It is the policy of the Federal Government

to save lives and protect property by

promoting fire safety in hotels, motels, and

all places of public accommodation affecting

commerce. The GSA’s travel programs adhere

to established fire safety guidelines and

survey accommodations that meet fire safety

standards when conducting surveys of

lodging costs for the purpose of establishing

locality per diem rates.

5. Federal Agency Compliance

a. Pursuant to FTR § 301–7.2(b)(2), it is the

responsibility of each agency when

authorizing travel to take appropriate

measures to influence employees, and others

who will procure commercial lodging in the

performance of official travel, to stay at a

firesafe approved accommodation.

b. Pursuant to FTR part 301–16, an agency

may not sponsor or fund in whole or in part

a conference at a place of public

accommodation that is not an approved

accommodation, unless a waiver is granted.

6. Other Fire Safety Responsibilities

a. Pursuant to FTR § 301–1.3(a)(2),

employees are strongly encouraged to stay in

an approved accommodation when

commercial lodging is required.

b. Pursuant to FTR § 301–1.202(b)(6), an

interviewee traveling to a pre-employment

interview is strongly encouraged to stay at an

approved accommodation when commercial

lodging is required.

7. Expiration Date

This bulletin remains in effect until

canceled or superseded.

8. For Further Information Contact

Jane E. Groat, General Services

Administration, Office of Governmentwide

Policy (MTT), Washington, DC 20405; e-mail,

jane.groat@gsa.gov; telephone (202) 501–

1538.

[FR Doc. 97–9400 Filed 4–10–97; 8:45 am]

BILLING CODE 6820–34–P

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.

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.
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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) AntiProteinase (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)
17834 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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)
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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
17836 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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 (TAm. 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 Ngeneous HDL (46223)

Olympus AU 800/Genzyme Ngeneous HDL (46222)

Roche Cobas FARA/Genzyme Ngeneous HDL (55213)

Roche Cobas Mira/Genzyme Ngeneous HDL (55212)

Technicon DAX 96/Genzyme Ngeneous 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)
17838 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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)
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 17839

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)
17840 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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)
17842 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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)
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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)
17844 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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 GravityDetect (07801)

Beckman Synchron CX 5 CE/DRI

Gravity-Detect (07804)

Beckman Synchron CX 5/DRI GravityDetect (07803)

Beckman Synchron CX 7/DRI GravityDetect (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 GravityDetect (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)
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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 FactorII (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 TriglyceridesGPO 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 antiCardiolipin IgG/IgM (qual) (58422)

Shield Diagnostics DIASTAT antiCardiolipin IgG/IgM (quant) (58421)

ANALYTE: Anti-Centromere Antibodies

(0487)

TEST SYSTEM, ASSAY,

EXAMINATION:

Shield Diagnostics DIASTAT AntiCentromere Kit (qual) (58423)

Shield Diagnostics DIASTAT AntiCentromere Kit (semi-quant)

(58312)

ANALYTE: Anti-DNA Antibodies (0435)

TEST SYSTEM, ASSAY,

EXAMINATION:

TheraTest Laborat EL-ANA/

6(ssDNA,dsDNA,Sm,RNP/Sm,SSA,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)
17846 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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,Jo1 (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 antiGBM (qual) (58427)

Shield Diagnostics DIASTAT antiGBM (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 AntiPR3 (cANCA) (qual) (58424)

Shield Diagnostics DIASTAT AntiPR3 (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,SSA,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,SSA,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/
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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 AntiThyroglobulin (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 AntiThyroid 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
17848 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices

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
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: Procedures for Requests To Use

Child Care and Development Fund for

Construction or Major Renovation of

Child Care Facilities.

OMB No: New Collection.

Description; The Personal

Responsibility and Work Opportunity

Reconciliation Act of 1996 (Public Law

104–193) allows tribal grantees to use

Child Care and Development Fund

(CCDF) grant awards for construction

and renovation of child care facilities. A

tribal grantee must first request and

receive approval from the

Administration for Children and

Families (ACF) before using CCDF funds

for construction or major renovation.

This information collection contains the

statutorily-mandated uniform

procedures for the solicitation and

consideration of requests. Respondents

will be CCDF tribal grantees requesting

to use the CCDF funds for construction

or major renovation.

Respondents: Tribal Governments.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses per

respondent

Average

burden hours

per

response

Total

burden hours

Construction and renovation collection ............................................................ 100 1 20 2,000

Estimated Total Annual Burden Hours: 2,000.

In compliance with the requirements

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments on: (a) whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: April 7, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–9396 Filed 4–10–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 97M–0136]

Thoratec Laboratories Corp.;

Premarket Approval of Thoratec

Ventricular Assist Device System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Thoratec

Laboratories Corp., Berkeley, CA, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of Thoratec Ventricular Assist Device

System. After reviewing the

recommendation of the Circulatory

Systems Devices Panel, FDA’s Center for

Devices and Radiological Health (CDRH)

notified the applicant, by letter of

December 20, 1995, of the approval of

the application.

DATES: Petitions for administrative

review by May 12, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review, to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT: Dina

A. Justice, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8262.

SUPPLEMENTARY INFORMATION: On June

26, 1992, Thoratec Laboratories Corp.,

Berkeley, CA 94710, submitted to CDRH

an application for premarket approval of

Thoratec Ventricular Assist Device

System. The device is a ventricular

assist device and is intended as a bridge

to cardiac transplantation for use in

patients suffering from end-stage heart

failure. The patient should meet all of

the following criteria: (1) Candidate for

cardiac transplantation, (2) imminent

risk of dying before donor heart

procurement, and (3) dependence on, or

incomplete response to, continued

vasopressor support.

On December 5, 1994, the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the