FDA product code GPQ: Antigen, Cf, Spotted Fever Group
GPQ is the FDA product code for antigen, cf, spotted fever group. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. Devices under GPQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, Spotted Fever Group |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GPQ devices
openFDA lists no recalls for product code GPQ.
Frequently asked questions
What is FDA product code GPQ?
GPQ is the FDA product code for antigen, cf, spotted fever group. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is GPQ?
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 GPQ
- Run a recall and safety report across every GPQ manufacturer
- Watch product code GPQ 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times