FDA product code GQK: Antigen, Cf, Lymphocytic Choriomeningitis Virus
GQK is the FDA product code for antigen, cf, lymphocytic choriomeningitis virus. It is a Class I device, regulated under 21 CFR 866.3360 and reviewed by the Microbiology panel. Devices under GQK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, Lymphocytic Choriomeningitis Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3360 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GQK devices
openFDA lists no recalls for product code GQK.
Frequently asked questions
What is FDA product code GQK?
GQK is the FDA product code for antigen, cf, lymphocytic choriomeningitis virus. It is a Class I device, regulated under 21 CFR 866.3360 and reviewed by the Microbiology panel.
What device class is GQK?
Class I, regulation 21 CFR 866.3360. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GQK
- Run a recall and safety report across every GQK manufacturer
- Watch product code GQK 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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