Opgen Inc

FDA Filings

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

USANASDAQOPGNDUNS 119234263
FDA Registration(s)
Registration Number3007065145
FEI Number3007065145
NameOPGEN, INC.
Owner & OperatorOPGEN, INC.
Contact Address708 Quince Orchard Rd
Gaithersburg MD 20878 US
Official Correspondent
  • Autumn R Collasius
  • 01-301-8699683-1293
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address708 Quince Orchard Rd
Gaithersburg, MD 20878 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Opgen, Inc.
Acuitas KT03U01-22021-10-14
Opgen, Inc.
Acuitas KT03U01-12021-10-14
OpGen, Inc.
Acuitas AMR Gene Panel2021-09-30
OPGEN, INC.
Gram-Negative QuickFISH BC2013-08-09
OPGEN, INC.
Enterococcus QuickFISH BC2013-01-16
OPGEN, INC.
Staphylococcus QuickFISH BC2012-04-12
OPGEN, INC.
QuickFISH Coverslip mixing template2012-04-12
OPGEN, INC.
PNA FISH Staining Dish2012-04-12
OPGEN, INC.
PNA FISH Mounting Medium2012-04-12
OPGEN, INC.
Quickfix-22012-04-12
OPGEN, INC.
Quickfix-12012-04-12
OPGEN, INC.
PNA FISH GNR Fixation Solution2012-04-12
OPGEN, INC.
PNA FISH Fixation Solution2012-04-12
OPGEN, INC.
AdvanDx 10uL Pipette2012-04-12
OPGEN, INC.
PNA FISH Wash Solution2012-04-12
OPGEN, INC.
AdvanDx Filter Vial2012-04-12
OPGEN, INC.
C. albicans/C. glabrata PNA FISH2012-03-20
OPGEN, INC.
GNR Traffic Light PNA FISH2011-10-06
OPGEN, INC.
Yeast Traffic Light PNA FISH2011-10-06
OPGEN, INC.
S. aureus/CNS PNA FISH2011-10-06
OPGEN, INC.
S. aureus PNA FISH2011-10-06
OPGEN, INC.
E. faecalis/OE PNA FISH2011-10-06
OPGEN, INC.
PNA FISH WATER BATH2007-09-13
OPGEN, INC.
PNA FISH WORKSTATION2006-09-29
OPGEN, INC.
AdvanDx SlideStation 102006-09-29
OPGEN, INC.
Yeast Traffic Light PNA FISH Control Slides2005-12-01
OPGEN, INC.
S. aureus/CNS PNA FISH Control Slides2005-12-01
OPGEN, INC.
S. aureus PNA FISH Control Slides2005-12-01
OPGEN, INC.
QuickFISH Slide2005-12-01
OPGEN, INC.
GNR Traffic Light PNA FISH Control Slides2005-12-01
OPGEN, INC.
GBS PNA FISH Control Slides2005-12-01
OPGEN, INC.
E. faecalis/OE PNA FISH Control Slides2005-12-01
OPGEN, INC.
E. coli/P. aeruginosa PNA FISH Control Slides2005-12-01
OPGEN, INC.
C. albicans/C. glabrata PNA FISH Control Slides2005-12-01
OPGEN, INC.
C. albicans PNA FISH Control Slides2005-12-01
OPGEN, INC.
PNA FISH Dual Band Filter2004-09-10
OPGEN, INC.
AdvanDx Microscope Filter2004-09-10
OPGEN, INC.
AdvanDx Metal Halide Filter2004-09-10
OPGEN, INC.
PNA FISH MICROSCOPE SLIDES2004-07-22
OPGEN, INC.
PNA FISH COVERSLIPS2004-07-22

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