FDA product code NFZ: Test, Creatinine, Over The Counter
NFZ is the FDA product code for test, creatinine, over the counter. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Toxicology panel. Devices under NFZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Creatinine, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.1225 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for NFZ devices
openFDA lists no recalls for product code NFZ.
Frequently asked questions
What is FDA product code NFZ?
NFZ is the FDA product code for test, creatinine, over the counter. It is a Class II device, regulated under 21 CFR 862.1225 and reviewed by the Clinical Toxicology panel.
What device class is NFZ?
Class II, regulation 21 CFR 862.1225. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NFZ
- Run a recall and safety report across every NFZ manufacturer
- Watch product code NFZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times