Regenesys

FDA Filings

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

FDA Registration(s)
Registration Number3016722879
FEI Number3016722879
NameREGENESYS
Owner & OperatorRegenesys
Contact Address6300 Fairlane Dr
Oakland CA 94611 US
Official Correspondent
  • Evan Chi
  • 1-510-3258744-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6300 Fairlane Dr
Oakland, CA 94611 US
Establishment TypeManufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
REGENESYS
COVID-19 Corona Virus Real-Time Kit2020-03-26

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