FDA product code GSP: Antiserum, Fluorescent, Campylobacter Fetus
GSP is the FDA product code for antiserum, fluorescent, campylobacter fetus. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel. Devices under GSP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, Campylobacter Fetus |
| Device class | Class I |
| Regulation | 21 CFR 866.3110 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GSP devices
openFDA lists no recalls for product code GSP.
Frequently asked questions
What is FDA product code GSP?
GSP is the FDA product code for antiserum, fluorescent, campylobacter fetus. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel.
What device class is GSP?
Class I, regulation 21 CFR 866.3110. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GSP
- Run a recall and safety report across every GSP manufacturer
- Watch product code GSP 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.
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