NFZ · Test, Creatinine, Over The Counter
Clinical Chemistry · 21 CFR 862.1225 · Class 2
Overview
| Product Code | NFZ |
|---|---|
| Device Name | Test, Creatinine, Over The Counter |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
