Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 866  /  Sec. 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).