FDA product code GOH: Antigens, Cf (Including Cf Control), Poliovirus 1-3
GOH is the FDA product code for antigens, cf (including cf control), poliovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel. Devices under GOH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf (Including Cf Control), 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 GOH devices
openFDA lists no recalls for product code GOH.
Frequently asked questions
What is FDA product code GOH?
GOH is the FDA product code for antigens, cf (including cf control), 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 GOH?
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 GOH
- Run a recall and safety report across every GOH manufacturer
- Watch product code GOH 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.