21 CFR 866.5260
§ 866.5260 Complement C
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.5260, § 866.5260 Complement C, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89627
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Full text
(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.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.