StacksVerified U.S. regulatory reference

21 CFR §862.1565

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.