JNK · Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase
Clinical Chemistry · 21 CFR 862.1670 · Class 1
Overview
| Product Code | JNK |
|---|---|
| Device Name | Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase |
| Regulation | 21 CFR 862.1670 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A sorbitol dehydrogenase test system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders such as cirrhosis or acute hepatitis.
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.
Cleared Devices (0)
No cleared devices on record.
