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21 CFR 866.5080

§ 866.5080

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 866.5080, § 866.5080, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89611
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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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.