{"data":{"id":"us/21-cfr-864.7875","jurisdiction":"us","citation":"21 CFR 864.7875","heading":"Thrombin time test.","body":"(a) Identification. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding 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 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":"21fbafdbf3a617241555a0edce88e6bdae2496a1577fd76633d9c741fa4c14f3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7825","next":"us/21-cfr-864.7900"},"notice":"GroundRules: Original legal text. Not legal advice."}