FDA product code LSN: Dna-Reagents, Shigella Spp.
LSN is the FDA product code for dna-reagents, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel. Devices under LSN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Shigella Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for LSN devices
openFDA lists no recalls for product code LSN.
Frequently asked questions
What is FDA product code LSN?
LSN is the FDA product code for dna-reagents, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel.
What device class is LSN?
Class II, regulation 21 CFR 866.3660. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code LSN
- Run a recall and safety report across every LSN manufacturer
- Watch product code LSN 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.