FDA product code NGI: Test, Morphine, Over The Counter
NGI is the FDA product code for test, morphine, over the counter. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. Devices under NGI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Morphine, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.3640 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NGI devices
openFDA lists no recalls for product code NGI.
Frequently asked questions
What is FDA product code NGI?
NGI is the FDA product code for test, morphine, over the counter. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is NGI?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NGI
- Run a recall and safety report across every NGI manufacturer
- Watch product code NGI 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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