Alpha-2-macroglobulin immunological test system.

§866.5620
Alpha-2-macroglobulin immunological test system.
Identification. An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
Classification. Class II (performance standards).