21 CFR § 866.5260 - Complement C3b 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).
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