FDA product code GPE: Antisera, Positive Control, Echinococcus Spp.
GPE is the FDA product code for antisera, positive control, echinococcus spp.. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel. Devices under GPE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Positive Control, Echinococcus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3200 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GPE devices
openFDA lists no recalls for product code GPE.
Frequently asked questions
What is FDA product code GPE?
GPE is the FDA product code for antisera, positive control, echinococcus spp.. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel.
What device class is GPE?
Class I, regulation 21 CFR 866.3200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GPE
- Run a recall and safety report across every GPE manufacturer
- Watch product code GPE 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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