FDA product code GOF: Antisera, Neutralization, Poliovirus 1-3
GOF is the FDA product code for antisera, neutralization, poliovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel. Devices under GOF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralization, Poliovirus 1-3 |
| Device class | Class I |
| Regulation | 21 CFR 866.3405 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GOF devices
openFDA lists no recalls for product code GOF.
Frequently asked questions
What is FDA product code GOF?
GOF is the FDA product code for antisera, neutralization, poliovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel.
What device class is GOF?
Class I, regulation 21 CFR 866.3405. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GOF
- Run a recall and safety report across every GOF manufacturer
- Watch product code GOF 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.