21 CFR 862.1565 — Nadp Reduction, 6-Phosphogluconate Dehydrogenase

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1565

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.

Classification Rationale

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.

Product Codes