FDA product code GTA: Antisera, All, Serratia Marcesans
GTA is the FDA product code for antisera, all, serratia marcesans. It is a Class I device, regulated under 21 CFR 866.3630 and reviewed by the Microbiology panel. Devices under GTA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All, Serratia Marcesans |
| Device class | Class I |
| Regulation | 21 CFR 866.3630 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GTA devices
openFDA lists no recalls for product code GTA.
Frequently asked questions
What is FDA product code GTA?
GTA is the FDA product code for antisera, all, serratia marcesans. It is a Class I device, regulated under 21 CFR 866.3630 and reviewed by the Microbiology panel.
What device class is GTA?
Class I, regulation 21 CFR 866.3630. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GTA
- Run a recall and safety report across every GTA manufacturer
- Watch product code GTA 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.