JND · Nadp Reduction, 6-Phosphogluconate Dehydrogenase
Clinical Chemistry · 21 CFR 862.1565 · Class 1
Overview
| Product Code | JND |
|---|---|
| Device Name | Nadp Reduction, 6-Phosphogluconate Dehydrogenase |
| Regulation | 21 CFR 862.1565 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
