Alpha -2-macroglobulin immunological test system.

(a) 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. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]