FDA product code GND: Antigen, Iha, T. Cruzi
GND is the FDA product code for antigen, iha, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. Devices under GND reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Iha, 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 GND devices
openFDA lists no recalls for product code GND.
Frequently asked questions
What is FDA product code GND?
GND is the FDA product code for antigen, iha, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is GND?
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 GND
- Run a recall and safety report across every GND manufacturer
- Watch product code GND 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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