Code of Federal Regulations Title 21. Food and Drugs § 21.866.5580 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).