FDA product code GPR: Antiserum, Cf, Q Fever
GPR is the FDA product code for antiserum, cf, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. Devices under GPR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Cf, Q Fever |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GPR devices
openFDA lists no recalls for product code GPR.
Frequently asked questions
What is FDA product code GPR?
GPR is the FDA product code for antiserum, cf, q fever. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPR?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GPR
- Run a recall and safety report across every GPR manufacturer
- Watch product code GPR 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.