FDA product code GTF: Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp.
GTF is the FDA product code for antisera, bethesda - ballerup polyvalent, citrobacter spp.. It is a Class I device, regulated under 21 CFR 866.3125 and reviewed by the Microbiology panel. Devices under GTF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Bethesda - Ballerup Polyvalent, Citrobacter Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3125 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GTF devices
openFDA lists no recalls for product code GTF.
Frequently asked questions
What is FDA product code GTF?
GTF is the FDA product code for antisera, bethesda - ballerup polyvalent, citrobacter spp.. It is a Class I device, regulated under 21 CFR 866.3125 and reviewed by the Microbiology panel.
What device class is GTF?
Class I, regulation 21 CFR 866.3125. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GTF
- Run a recall and safety report across every GTF manufacturer
- Watch product code GTF 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.