{"data":{"id":"us/21-cfr-864.5425","jurisdiction":"us","citation":"21 CFR 864.5425","heading":"Multipurpose system for in vitro coagulation studies.","body":"(a) Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.\n(b) Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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 F—Automated and Semi-Automated Hematology Devices"],"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":"3ccf2ad0f4101b512f9de0f0d72d54d45dc2aed2489fa812c3d4c49cc406380e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.5400","next":"us/21-cfr-864.5430"},"notice":"GroundRules: Original legal text. Not legal advice."}