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e-CFR data is current as of July 13, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5080


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§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).

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