Regulations last checked for updates: Feb 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
cite as: 21 CFR 866.5080