FDA product code LSJ: Antigen, Rubella, Other
LSJ is the FDA product code for antigen, rubella, other. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. Devices under LSJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Rubella, Other |
| 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 LSJ devices
openFDA lists no recalls for product code LSJ.
Frequently asked questions
What is FDA product code LSJ?
LSJ is the FDA product code for antigen, rubella, other. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is LSJ?
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 LSJ
- Run a recall and safety report across every LSJ manufacturer
- Watch product code LSJ 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.