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 |