FDA product code GNQ: Antigen, Cf (Including Cf Control), Epstein-Barr Virus
GNQ is the FDA product code for antigen, cf (including cf control), epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. Devices under GNQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf (Including Cf Control), Epstein-Barr Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3235 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GNQ devices
openFDA lists no recalls for product code GNQ.
Frequently asked questions
What is FDA product code GNQ?
GNQ is the FDA product code for antigen, cf (including cf control), epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel.
What device class is GNQ?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GNQ
- Run a recall and safety report across every GNQ manufacturer
- Watch product code GNQ 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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