FDA product code GQD: Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee
GQD is the FDA product code for antigens, cf (including cf control), equine encephalitis virus, eee, wee. It is a Class I device, regulated under 21 CFR 866.3240 and reviewed by the Microbiology panel. Devices under GQD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf (Including Cf Control), Equine Encephalitis Virus, Eee, Wee |
| Device class | Class I |
| Regulation | 21 CFR 866.3240 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GQD devices
openFDA lists no recalls for product code GQD.
Frequently asked questions
What is FDA product code GQD?
GQD is the FDA product code for antigens, cf (including cf control), equine encephalitis virus, eee, wee. It is a Class I device, regulated under 21 CFR 866.3240 and reviewed by the Microbiology panel.
What device class is GQD?
Class I, regulation 21 CFR 866.3240. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GQD
- Run a recall and safety report across every GQD manufacturer
- Watch product code GQD 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.