21 CFR § 866.5580 - Alpha-1-lipoprotein immunological test system.

§ 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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