FDA product code GME: Antisera, Fluorescent, Cryptococcus Neoformans
GME is the FDA product code for antisera, fluorescent, cryptococcus neoformans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. Devices under GME reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Cryptococcus Neoformans |
| Device class | Class II |
| Regulation | 21 CFR 866.3165 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GME devices
openFDA lists no recalls for product code GME.
Frequently asked questions
What is FDA product code GME?
GME is the FDA product code for antisera, fluorescent, cryptococcus neoformans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.
What device class is GME?
Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GME
- Run a recall and safety report across every GME manufacturer
- Watch product code GME 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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