FDA product code GPI: Antigen, Bentonite Flocculation, Trichinella Spiralis
GPI is the FDA product code for antigen, bentonite flocculation, trichinella spiralis. It is a Class I device, regulated under 21 CFR 866.3850 and reviewed by the Microbiology panel. Devices under GPI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, 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 GPI devices
openFDA lists no recalls for product code GPI.
Frequently asked questions
What is FDA product code GPI?
GPI is the FDA product code for antigen, 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 GPI?
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 GPI
- Run a recall and safety report across every GPI manufacturer
- Watch product code GPI 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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