FDA product code GQA: Antigens, Ha (Including Ha Control), Reovirus 1-3
GQA is the FDA product code for antigens, ha (including ha control), reovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3470 and reviewed by the Microbiology panel. Devices under GQA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Ha (Including Ha 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 GQA devices
openFDA lists no recalls for product code GQA.
Frequently asked questions
What is FDA product code GQA?
GQA is the FDA product code for antigens, ha (including ha 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 GQA?
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 GQA
- Run a recall and safety report across every GQA manufacturer
- Watch product code GQA 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.
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