{"data":{"id":"us/21-cfr-864.7900","jurisdiction":"us","citation":"21 CFR 864.7900","heading":"Thromboplastin generation test.","body":"(a) Identification. A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.\n(b) Classification. Class I (general controls). This 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":"1a67ee4af1d6b8c8e88a7284bb3786229c3f38b11e0b0f391e6c54abf4e69177","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7875","next":"us/21-cfr-864.7925"},"notice":"GroundRules: Original legal text. Not legal advice."}