{"data":{"id":"us/21-cfr-866.4100","jurisdiction":"us","citation":"21 CFR 866.4100","heading":"Complement reagent.","body":"(a) Identification. A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.","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 E—Immunology Laboratory Equipment and Reagents"],"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":"df18bfb2873e61b898cab2073b9d47c0565b05c0e3ef9002cbe4ff9741b9427f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.4070","next":"us/21-cfr-866.4500"},"notice":"GroundRules: Original legal text. Not legal advice."}