§ 866.5580. Alpha-1-lipoprotein immunological test system.
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/us/cfr/t21/s§ 866.5580·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).