FDA product code GQY: Antigen, Ha (Including Ha Control), Mumps Virus
GQY is the FDA product code for antigen, ha (including ha control), mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel. Devices under GQY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Ha (Including Ha Control), Mumps Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3380 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GQY devices
openFDA lists no recalls for product code GQY.
Frequently asked questions
What is FDA product code GQY?
GQY is the FDA product code for antigen, ha (including ha control), mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel.
What device class is GQY?
Class I, regulation 21 CFR 866.3380. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GQY
- Run a recall and safety report across every GQY manufacturer
- Watch product code GQY 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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