FDA product code GNI: Antisera, Neutralization, Echovirus 1-34
GNI is the FDA product code for antisera, neutralization, echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel. Devices under GNI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralization, Echovirus 1-34 |
| Device class | Class I |
| Regulation | 21 CFR 866.3205 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GNI devices
openFDA lists no recalls for product code GNI.
Frequently asked questions
What is FDA product code GNI?
GNI is the FDA product code for antisera, neutralization, echovirus 1-34. It is a Class I device, regulated under 21 CFR 866.3205 and reviewed by the Microbiology panel.
What device class is GNI?
Class I, regulation 21 CFR 866.3205. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GNI
- Run a recall and safety report across every GNI manufacturer
- Watch product code GNI 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times