{"data":{"id":"us/21-cfr-864.7720","jurisdiction":"us","citation":"21 CFR 864.7720","heading":"Prothrombin consumption test.","body":"(a) Identification. A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.","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":"b8fd46a0cb555a49c1657d86eb2732996b05ceef4c246094404cf41e5b44e7c6","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7695","next":"us/21-cfr-864.7735"},"notice":"GroundRules: Original legal text. Not legal advice."}