Alpha-1-antichymotrypsin immunological test system.

21 C.F.R. § 866.5080
in effectEffective: 2024-07-01
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(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).

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