FDA product code GSD: Antiserum, Fluorescent, Erysipelothrix Rhusiopathiae
GSD is the FDA product code for antiserum, fluorescent, erysipelothrix rhusiopathiae. It is a Class I device, regulated under 21 CFR 866.3250 and reviewed by the Microbiology panel. Devices under GSD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, 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 GSD devices
openFDA lists no recalls for product code GSD.
Frequently asked questions
What is FDA product code GSD?
GSD is the FDA product code for antiserum, fluorescent, erysipelothrix rhusiopathiae. It is a Class I device, regulated under 21 CFR 866.3250 and reviewed by the Microbiology panel.
What device class is GSD?
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 GSD
- Run a recall and safety report across every GSD manufacturer
- Watch product code GSD 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.