(a) Identification. A beta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
(b) Classification. Class II (performance standards).