21 C.F.R. § 866.5260
Complement C 3b inactivator immunological test system.
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).