21 C.F.R. § 866.5200

Current through October 31, 2024
Section 866.5200 - Carbonic anhydrase B and C immunological test system
(a)Identification. A carbonic anhydrase B and C immunological test system is a device that consists of the reagents used to measure by immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9 .

21 C.F.R. §866.5200

47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312 , Jan. 14, 2000