Find Laws Find Lawyers Free Legal Forms USA State Laws

CFR

866.5580—Alpha -1-lipoprotein immuno-logical 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).
Tips