{"data":{"id":"us/21-cfr-864.7060","jurisdiction":"us","citation":"21 CFR 864.7060","heading":"Antithrombin III assay.","body":"(a) Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).\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 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart H—Hematology Kits and Packages"],"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":"27e826e1c9405e1ba848cbdfb9b16f609da56afd84c7c2bda2ff7b0f73d43fad","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7040","next":"us/21-cfr-864.7100"},"notice":"GroundRules: Original legal text. Not legal advice."}