FDA product code GQZ: Antiserum, Neutralization, Mumps Virus
GQZ is the FDA product code for antiserum, neutralization, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel. Devices under GQZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Neutralization, 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 GQZ devices
openFDA lists no recalls for product code GQZ.
Frequently asked questions
What is FDA product code GQZ?
GQZ is the FDA product code for antiserum, neutralization, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel.
What device class is GQZ?
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 GQZ
- Run a recall and safety report across every GQZ manufacturer
- Watch product code GQZ 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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