21 CFR 866.4100
§ 866.4100 Complement reagent.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.4100, § 866.4100 Complement reagent, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89597
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Full text
(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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.