{"data":{"id":"us/21-cfr-864.7695","jurisdiction":"us","citation":"21 CFR 864.7695","heading":"Platelet factor 4 radioimmunoassay.","body":"(a) Identification. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.\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":"45b0068f1a85ccefe8d39ef9d9ec8310e309a2700bc92e6a1f36bf7da87b1fa3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7675","next":"us/21-cfr-864.7720"},"notice":"GroundRules: Original legal text. Not legal advice."}