The following data is part of a De Novo classification by R-biopharm Ag with the FDA for Ridascreen Norovirus 3rd Generation Eia.
| DeNovo ID | DEN110001 |
| Device Name: | RIDASCREEN NOROVIRUS 3RD GENERATION EIA |
| Classification | Norovirus Serological Reagent |
| Applicant | R-Biopharm AG 150 Cherry Lane Rd East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Product Code | OUC |
| CFR Regulation Number | 866.3395 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K093295 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2011-02-16 |
| Decision Date | 2011-02-23 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049095030079 | DEN110001 | 000 |