FDA product code GNF: Antigen, Cf, T. Cruzi
GNF is the FDA product code for antigen, cf, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. Devices under GNF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, T. Cruzi |
| Device class | Class I |
| Regulation | 21 CFR 866.3870 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GNF devices
openFDA lists no recalls for product code GNF.
Frequently asked questions
What is FDA product code GNF?
GNF is the FDA product code for antigen, cf, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is GNF?
Class I, regulation 21 CFR 866.3870. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GNF
- Run a recall and safety report across every GNF manufacturer
- Watch product code GNF 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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