21 CFR § 866.5260 Immunology and Microbiology Devices

§ 866.5260 Complement C3b inactivator immunological test system.

Current through Sep 8, 2026 · Read all of Part 866

(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).

← § 866.5250 Complement C1 inhibitor (inactivator) immunological test system.§ 866.5270 C-reactive protein immunological test system. →