FDA product code GSF: Antigen, Erysipelothrix Rhusiopathiae
GSF is the FDA product code for antigen, erysipelothrix rhusiopathiae. It is a Class I device, regulated under 21 CFR 866.3250 and reviewed by the Microbiology panel. Devices under GSF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Erysipelothrix Rhusiopathiae |
| Device class | Class I |
| Regulation | 21 CFR 866.3250 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GSF devices
openFDA lists no recalls for product code GSF.
Frequently asked questions
What is FDA product code GSF?
GSF is the FDA product code for antigen, erysipelothrix rhusiopathiae. It is a Class I device, regulated under 21 CFR 866.3250 and reviewed by the Microbiology panel.
What device class is GSF?
Class I, regulation 21 CFR 866.3250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GSF
- Run a recall and safety report across every GSF manufacturer
- Watch product code GSF 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.