FDA product code GPH: Antiserum, Bentonite Flocculation, Trichinella Spiralis
GPH is the FDA product code for antiserum, bentonite flocculation, trichinella spiralis. It is a Class I device, regulated under 21 CFR 866.3850 and reviewed by the Microbiology panel. Devices under GPH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Bentonite Flocculation, Trichinella Spiralis |
| Device class | Class I |
| Regulation | 21 CFR 866.3850 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GPH devices
openFDA lists no recalls for product code GPH.
Frequently asked questions
What is FDA product code GPH?
GPH is the FDA product code for antiserum, bentonite flocculation, trichinella spiralis. It is a Class I device, regulated under 21 CFR 866.3850 and reviewed by the Microbiology panel.
What device class is GPH?
Class I, regulation 21 CFR 866.3850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GPH
- Run a recall and safety report across every GPH manufacturer
- Watch product code GPH 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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