§866.5620. Alpha -2-macroglobulin immunological test system.
21 C.F.R. § 866.5620
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 (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.
Notes, amendments, and revision history
Amendments
[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.
Amendments
[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]