21 C.F.R. § 866.5080
Alpha -1-antichymotrypsin immunological test system.
Cite as 21 C.F.R. § 866.5080 (2026)
(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).