FDA product code GQE: Antisera, Neutralization, All Types, Rhinovirus
GQE is the FDA product code for antisera, neutralization, all types, rhinovirus. It is a Class I device, regulated under 21 CFR 866.3490 and reviewed by the Microbiology panel. Devices under GQE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralization, All Types, Rhinovirus |
| Device class | Class I |
| Regulation | 21 CFR 866.3490 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GQE devices
openFDA lists no recalls for product code GQE.
Frequently asked questions
What is FDA product code GQE?
GQE is the FDA product code for antisera, neutralization, all types, rhinovirus. It is a Class I device, regulated under 21 CFR 866.3490 and reviewed by the Microbiology panel.
What device class is GQE?
Class I, regulation 21 CFR 866.3490. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GQE
- Run a recall and safety report across every GQE manufacturer
- Watch product code GQE 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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