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