FDA product code GQB: Antigens, Cf (Including Cf Control), Reovirus 1-3
GQB is the FDA product code for antigens, cf (including cf control), reovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3470 and reviewed by the Microbiology panel. Devices under GQB 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), 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 GQB devices
openFDA lists no recalls for product code GQB.
Frequently asked questions
What is FDA product code GQB?
GQB is the FDA product code for antigens, cf (including cf control), 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 GQB?
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 GQB
- Run a recall and safety report across every GQB manufacturer
- Watch product code GQB 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.