21 CFR 862.1805 — Acid, Trifluoroacetic, Vitamin A, Hexane Extraction
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1805
Identification
A vitamin A test system is a device intended to measure vitamin A in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin A deficiency conditions, including night blindness, or skin, eye, or intestinal disorders.
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 |
|---|---|---|---|---|
| JOA | Acid, Trifluoroacetic, Vitamin A, Hexane Extraction | 1 | 0 |
