21 CFR § 866.5080 Immunology and Microbiology Devices

§ 866.5080 Alpha-1-antichymotrypsin immunological test system.

Current through Sep 8, 2026 · Read all of Part 866

(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).

← § 866.5065 Human allotypic marker immunological test system.§ 866.5090 Antimitochondrial antibody immunological test system. →