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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: 21CFR862.1085]
 See Related Information on 862.1085 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 B--Clinical Chemistry Test Systems

Sec. 862.1085 Angiotensin I and renin test system.

(a)Identification. An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.

(b)Classification. Class II.
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