{"data":{"id":"us/21-cfr-866.5260","jurisdiction":"us","citation":"21 CFR 866.5260","heading":"Complement C3b inactivator immunological test system.","body":"(a) Identification. A complement C3b inactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the diagnosis of inherited antibody dysfunction.\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 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart F—Immunological Test Systems"],"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":"9d6c053645c184a2d4c2136792e94aeddec0f892d7d39134ba5515e50e5175dc","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5250","next":"us/21-cfr-866.5270"},"notice":"GroundRules: Original legal text. Not legal advice."}