FDA product code GMB: Light, Wood'S, Fluorescence
GMB is the FDA product code for light, wood's, fluorescence. It is a Class I device, regulated under 21 CFR 866.2600 and reviewed by the Microbiology panel. Devices under GMB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Light, Wood'S, Fluorescence |
| Device class | Class I |
| Regulation | 21 CFR 866.2600 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for GMB devices
openFDA lists no recalls for product code GMB.
Frequently asked questions
What is FDA product code GMB?
GMB is the FDA product code for light, wood's, fluorescence. It is a Class I device, regulated under 21 CFR 866.2600 and reviewed by the Microbiology panel.
What device class is GMB?
Class I, regulation 21 CFR 866.2600. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GMB
- Run a recall and safety report across every GMB manufacturer
- Watch product code GMB 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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