21 C.F.R. § 866.5080

Alpha -1-antichymotrypsin immunological test system.

Last amended: 2016Year: 2026Length: 51 wordsSubsections: 1Official source

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).
21 C.F.R. § 866.5080: Alpha -1-antichymotrypsin immunological test system. | Justis AI