FDA product code NGB: Test, Glycosylated Hemoglobin, Over The Counter
NGB is the FDA product code for test, glycosylated hemoglobin, over the counter. It is a Class II device, regulated under 21 CFR 864.7470 and reviewed by the Clinical Toxicology panel. Devices under NGB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Glycosylated Hemoglobin, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 864.7470 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for NGB devices
openFDA lists no recalls for product code NGB.
Frequently asked questions
What is FDA product code NGB?
NGB is the FDA product code for test, glycosylated hemoglobin, over the counter. It is a Class II device, regulated under 21 CFR 864.7470 and reviewed by the Clinical Toxicology panel.
What device class is NGB?
Class II, regulation 21 CFR 864.7470. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NGB
- Run a recall and safety report across every NGB manufacturer
- Watch product code NGB 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.
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