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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, 2015]
[CITE: 21CFR866.5580]
See Related Information on Alpha-1-lipoprotein 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. 866.5580 Alpha-1-lipoprotein immunological test system.

(a) Identification. An alpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

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

The information on this page is current as of April 1 2015.

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

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