FDA product code GOJ: Antisera, Neutralization, Rubella
GOJ is the FDA product code for antisera, neutralization, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. Devices under GOJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralization, Rubella |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GOJ devices
openFDA lists no recalls for product code GOJ.
Frequently asked questions
What is FDA product code GOJ?
GOJ is the FDA product code for antisera, neutralization, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is GOJ?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GOJ
- Run a recall and safety report across every GOJ manufacturer
- Watch product code GOJ 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.
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