{"data":{"id":"us/21-cfr-866.5660","jurisdiction":"us","citation":"21 CFR 866.5660","heading":"Multiple autoantibodies immunological test system.","body":"(a) Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).\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":"79af19d28e92939a2d707ffb4c1599023c2be49eb9cc259d6c8b245922719be7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5640","next":"us/21-cfr-866.5665"},"notice":"GroundRules: Original legal text. Not legal advice."}