FDA product code GTE: Antisera, Arizona Spp., All
GTE is the FDA product code for antisera, arizona spp., all. It is a Class I device, regulated under 21 CFR 866.3035 and reviewed by the Microbiology panel. Devices under GTE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Arizona Spp., All |
| Device class | Class I |
| Regulation | 21 CFR 866.3035 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GTE devices
openFDA lists no recalls for product code GTE.
Frequently asked questions
What is FDA product code GTE?
GTE is the FDA product code for antisera, arizona spp., all. It is a Class I device, regulated under 21 CFR 866.3035 and reviewed by the Microbiology panel.
What device class is GTE?
Class I, regulation 21 CFR 866.3035. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GTE
- Run a recall and safety report across every GTE manufacturer
- Watch product code GTE 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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