21 CFR 862.1670 — Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1670
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JNK | Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase | 1 | 0 |
