§ 866.5620. Alpha-2-macroglobulin immunological test system.
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/us/cfr/t21/s§ 866.5620·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]