§ 866.5630. Beta-2-microglobulin immunological test system.
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/us/cfr/t21/s§ 866.5630·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
(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]