R Biopharm Ag

FDA Filings

This page includes the latest FDA filings for R Biopharm Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004061467
FEI Number3004061467
NameSean A Tinkey
Owner & OperatorR-BIOPHARM AG
Contact AddressAn der neuen Bergstrasse 17 --
Darmstadt DE-HE Hessen D-64297 DE
Official Correspondent
  • Fernanda Heiss
  • 49-6151-8102-762
US Agent
Importing Logistics Registration
ImporterR-Biopharm Inc.
Address870 Vossbrink Drive
Washington, MO 63090 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address870 Vossbrink Drive
Washington, MO 63090 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
R-Biopharm AG
RIDA® CCD-Inhibitor 2023-07-11
R-Biopharm AG
RIDA®GENE Norovirus GI/GII PG14452019-05-16
R-Biopharm AG
RIDASCREEN® Taenia solium IgG K77212019-05-16
R-Biopharm AG
RIDASCREEN® Echinococcus IgG K76212019-05-16
R-Biopharm AG
RIDASCREEN® Entamoeba histolytica IgG K17212019-05-16
R-Biopharm AG
RIDASCREEN® Norovirus 3rd Generation C1401US2019-05-16
Sean A Tinkey [R-BIOPHARM AG]
RIDA?GENE Norovirus GI/GII2017-09-28
Sean A Tinkey [R-BIOPHARM AG]
RIDA?GENE Norovirus GI/GII2017-09-28
Sean A Tinkey [R-BIOPHARM AG]
RIDASCREEN Taenia Solium IgG2017-09-01
R-Biopharm AG
RIDA GENE Norovirus GI/GII2017-08-21
Sean A Tinkey [R-BIOPHARM AG]
RIDASCREEN Echinococcus IgG2015-09-24
Sean A Tinkey [R-BIOPHARM AG]
RIDASCREEN? Norovirus 3rd Generation2011-03-28
R-Biopharm AG
RIDASCREEN NOROVIRUS 3RD GENERATION EIA2011-02-23
Sean A Tinkey [R-BIOPHARM AG]
RIDASCREEN? Entamoeba histolytica IgG2003-08-22

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