{"data":{"id":"us/21-cfr-864.2800","jurisdiction":"us","citation":"21 CFR 864.2800","heading":"Animal and human sera.","body":"(a) Identification. Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.\n(b) Classification. Class I (general controls). These devices are 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 C—Cell And Tissue Culture 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":"914c8b3a49f3816b1d462243e4073af7f095d460021bb6c1505fc80ceabcd695","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.2360","next":"us/21-cfr-864.2875"},"notice":"GroundRules: Original legal text. Not legal advice."}