{"data":{"id":"us/21-cfr-864.9650","jurisdiction":"us","citation":"21 CFR 864.9650","heading":"Quality control kit for blood banking reagents.","body":"(a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.\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 J—Products Used In Establishments That Manufacture Blood and Blood Products"],"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":"65e968df9bb190aa57b82c38fc447392ebe4dce73262d587a2adb901e6a94c78","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.9600","next":"us/21-cfr-864.9700"},"notice":"GroundRules: Original legal text. Not legal advice."}