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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]
[CITE: 21CFR862.3050]
 See Related Information on 862.3050 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart D--Clinical Toxicology Test Systems

Sec. 862.3050 Breath-alcohol test system.

(a)Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

(b)Classification. Class I.
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