FDA product code GPX: Antisera, Neutralizion, Reovirus 1-3
GPX is the FDA product code for antisera, neutralizion, reovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3470 and reviewed by the Microbiology panel. Devices under GPX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralizion, Reovirus 1-3 |
| Device class | Class I |
| Regulation | 21 CFR 866.3470 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GPX devices
openFDA lists no recalls for product code GPX.
Frequently asked questions
What is FDA product code GPX?
GPX is the FDA product code for antisera, neutralizion, reovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3470 and reviewed by the Microbiology panel.
What device class is GPX?
Class I, regulation 21 CFR 866.3470. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GPX
- Run a recall and safety report across every GPX manufacturer
- Watch product code GPX 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.