21 CFR 862.1815 — Hexane Extraction, Fluorescence, Vitamin E
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1815
Identification
A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JOB | Hexane Extraction, Fluorescence, Vitamin E | 1 | 1 |
