Virotech Diagnostics G M B H

FDA Filings

This page includes the latest FDA filings for Virotech Diagnostics G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8010933
FEI Number1000503600
NameMonce, Napoleon
Owner & OperatorVIROTECH Diagnostics GmbH
Contact AddressLoewenplatz 5
Ruesselsheim DE-HE Hessen 65428 DE
Official Correspondent
  • Dr. Dominik Florek
  • 49-6142-6909-27
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2851 Spafford St
Davis, CA 95618 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Monce, Napoleon [VIROTECH Diagnostics GmbH]
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit2018-06-07
Monce, Napoleon [VIROTECH Diagnostics GmbH]
Gold Standard Diagnostics Borrelia Burgdorferi B31 IgG Line Blot Test2016-12-16
Monce, Napoleon [VIROTECH Diagnostics GmbH]
Gold Standard Diagnostics Borrelia Burgdorferi B31 IgM Line2016-12-16
Monce, Napoleon [VIROTECH Diagnostics GmbH]
Gold Standard Diagnostics H. pylori IgA ELISA Test Kit2016-12-16
Monce, Napoleon [VIROTECH Diagnostics GmbH]
Gold Standard Diagnostics H. Pylori IgG ELISA Test Kit2016-12-16

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