JNZ · Fluorometric, Uroporphyrin
Clinical Chemistry · 21 CFR 862.1790 · Class 1
Overview
| Product Code | JNZ |
|---|---|
| Device Name | Fluorometric, Uroporphyrin |
| Regulation | 21 CFR 862.1790 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A uroporphyrin test system is a device intended to measure uroporphyrin in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.
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.
Cleared Devices (0)
No cleared devices on record.
