FDA product code LSF: Dna-Reagents, Epstein-Barr Virus
LSF is the FDA product code for dna-reagents, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. Devices under LSF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Epstein-Barr Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3235 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LSF devices
openFDA lists no recalls for product code LSF.
Frequently asked questions
What is FDA product code LSF?
LSF is the FDA product code for dna-reagents, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel.
What device class is LSF?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LSF
- Run a recall and safety report across every LSF manufacturer
- Watch product code LSF 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.