21 C.F.R. § 866.5260

Current through November 30, 2024
Section 866.5260 - Complement C[3b] inactivator immunological test system
(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).

21 C.F.R. §866.5260