21 C.F.R. § 866.5080

Current through October 31, 2024
Section 866.5080 - Alpha-1-antichymotrypsin immunological test system
(a)Identification. An alpha-1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.
(b)Classification. Class II (performance standards).

21 C.F.R. §866.5080