Monce Napoleon

FDA Filings

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

FDA Registration(s)

• Registration Number: 8010933
• FEI Number: 1000503600
• Name: Monce, Napoleon
• Owner & Operator: VIROTECH Diagnostics GmbH
• Contact Address: Loewenplatz 5 ; Ruesselsheim DE-HE Hessen 65428 DE
• Official Correspondent:
  • Dr. Dominik Florek
  • 49-6142-6909-27
• US Agent:
  • Monce, Napoleon
  • 530 7598000
  • NMonce@gsdx.us
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2851 Spafford St ; Davis, CA 95618 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K180264 | LSR Monce, Napoleon [VIROTECH Diagnostics GmbH]	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	2018-06-07
PMN K113847 | LSR Monce, Napoleon [VIROTECH Diagnostics GmbH]	Gold Standard Diagnostics Borrelia Burgdorferi B31 IgG Line Blot Test	2016-12-16
PMN K113846 | LSR Monce, Napoleon [VIROTECH Diagnostics GmbH]	Gold Standard Diagnostics Borrelia Burgdorferi B31 IgM Line	2016-12-16
PMN K110899 | LYR Monce, Napoleon [VIROTECH Diagnostics GmbH]	Gold Standard Diagnostics H. pylori IgA ELISA Test Kit	2016-12-16
PMN K110745 | LYR Monce, Napoleon [VIROTECH Diagnostics GmbH]	Gold Standard Diagnostics H. Pylori IgG ELISA Test Kit	2016-12-16