21 C.F.R. § 866.5620

Current through September 30, 2024
Section 866.5620 - 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 .

21 C.F.R. §866.5620

47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019