Code of Federal Regulations Title 21. Food and Drugs § 21.866.5240 Complement components immunological test system

(a) Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C_1q, C_1r, C_1s, C₂, C₃, C₄, C₅, C₆, C₇, C₈, and C₉, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

(b) Classification. Class II (performance standards).