FDA product code GOT: Antigen, B. Parapertussis
GOT is the FDA product code for antigen, b. parapertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel. Devices under GOT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, 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 GOT devices
openFDA lists no recalls for product code GOT.
Frequently asked questions
What is FDA product code GOT?
GOT is the FDA product code for antigen, b. parapertussis. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel.
What device class is GOT?
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 GOT
- Run a recall and safety report across every GOT manufacturer
- Watch product code GOT 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.