21 CFR 862.1095 — Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1095
Identification
An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.
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 § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | 1 | 3 |
