FDA product code GSX: Antisera, Acinetobacter Calcoaceticus, All Varieties
GSX is the FDA product code for antisera, acinetobacter calcoaceticus, all varieties. It is a Class I device, regulated under 21 CFR 866.3010 and reviewed by the Microbiology panel. Devices under GSX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Acinetobacter Calcoaceticus, All Varieties |
| Device class | Class I |
| Regulation | 21 CFR 866.3010 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GSX devices
openFDA lists no recalls for product code GSX.
Frequently asked questions
What is FDA product code GSX?
GSX is the FDA product code for antisera, acinetobacter calcoaceticus, all varieties. It is a Class I device, regulated under 21 CFR 866.3010 and reviewed by the Microbiology panel.
What device class is GSX?
Class I, regulation 21 CFR 866.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GSX
- Run a recall and safety report across every GSX manufacturer
- Watch product code GSX 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.