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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR866.5130]
 See Related Information on Alpha-1-antitrypsin immunological test system. 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 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES

Subpart F - Immunological Test Systems

Sec. 866.5130 Alpha-1-antitrypsin immunological test system.

(a) Identification. An alpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.

(b) Classification. Class II (performance standards).

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