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e-CFR data is current as of June 30, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5580


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§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).

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