{"data":{"id":"us/21-cfr-866.5350","jurisdiction":"us","citation":"21 CFR 866.5350","heading":"Fibrinopeptide A immunological test system.","body":"(a) Identification. A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may aid in the diagnosis and treatment of certain blood-clotting disorders.\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":"6ea8094848c9d21005f039cea41bc213caec126105f0878d0349115051f06ee5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5340","next":"us/21-cfr-866.5360"},"notice":"GroundRules: Original legal text. Not legal advice."}