FDA product code GQJ: Antiserum, Cf, Lymphocytic Choriomeningitis Virus
GQJ is the FDA product code for antiserum, cf, lymphocytic choriomeningitis virus. It is a Class I device, regulated under 21 CFR 866.3360 and reviewed by the Microbiology panel. Devices under GQJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, 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 GQJ devices
openFDA lists no recalls for product code GQJ.
Frequently asked questions
What is FDA product code GQJ?
GQJ is the FDA product code for antiserum, 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 GQJ?
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 GQJ
- Run a recall and safety report across every GQJ manufacturer
- Watch product code GQJ 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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