21 C.F.R. § 866.5200 Carbonic anhydrase B and C immunological test system.
Title 21 - Food and Drugs
(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. [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§ 866.5200 Carbonic anhydrase B and C immunological test system.
