21 C.F.R. § 862.1565

Current through September 30, 2024
Section 862.1565 - 6-Phosphogluconate dehydrogenase test system
(a)Identification. A 6-phosphogluconate dehydrogenase test system is a device intended to measure the activity of the enzyme 6-phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes. Measurements of 6-phosphogluconate dehydrogenase are used in the diagnosis and treatment of certain liver diseases (such as hepatitis) and anemias.
(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 the limitations in § 862.9 .

21 C.F.R. §862.1565

52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001