{"data":{"id":"us/21-cfr-866.5080","jurisdiction":"us","citation":"21 CFR 866.5080","heading":"Alpha-1-antichymotrypsin immunological test system.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart F—Immunological Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"265aecc57c4145441c3a8bc746c305dfffb1cff40712eddc634a27162db6539a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5065","next":"us/21-cfr-866.5090"},"notice":"GroundRules: Original legal text. Not legal advice."}