FDA product code GOW: Antisera, Agglutinating, B. Parapertussis
GOW is the FDA product code for antisera, agglutinating, b. parapertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel. Devices under GOW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Agglutinating, B. Parapertussis |
| Device class | Class I |
| Regulation | 21 CFR 866.3065 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GOW devices
openFDA lists no recalls for product code GOW.
Frequently asked questions
What is FDA product code GOW?
GOW is the FDA product code for antisera, agglutinating, b. parapertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel.
What device class is GOW?
Class I, regulation 21 CFR 866.3065. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GOW
- Run a recall and safety report across every GOW manufacturer
- Watch product code GOW 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