21 C.F.R. § 866.5260

Complement C 3b inactivator immunological test system.

Last amended: 2016Year: 2026Length: 65 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 866.5260 (2026)

(a) Identification. A complement C 3b inactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C 3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C 3b inactivator aids in the diagnosis of inherited antibody dysfunction. (b) Classification. Class II (performance standards).
21 C.F.R. § 866.5260: Complement C 3b inactivator immunological test system. | Justis AI