FDA product code GQF: Antiserum, Neutralization, Respiratory Syncytial Virus
GQF is the FDA product code for antiserum, neutralization, respiratory syncytial virus. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel. Devices under GQF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Neutralization, Respiratory Syncytial Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3480 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GQF devices
openFDA lists no recalls for product code GQF.
Frequently asked questions
What is FDA product code GQF?
GQF is the FDA product code for antiserum, neutralization, respiratory syncytial virus. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel.
What device class is GQF?
Class I, regulation 21 CFR 866.3480. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GQF
- Run a recall and safety report across every GQF manufacturer
- Watch product code GQF 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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