Genmark Diagnostics Inc

FDA Filings

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

USANASDAQGNMKDUNS 962104217
FDA Registration(s)
Registration Number3008632402
FEI Number3008632402
NameGENMARK DIAGNOSTICS, INC.
Owner & OperatorGenMark Diagnostics, Inc.
Contact AddressGenMark Diagnostics, Inc. 5964 La Place Ct, Suite 100
Carlsbad CA 92008 US
Official Correspondent
  • Alan B Maderazo
  • x-760-4484308-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressGenMark Diagnostics, Inc. 5964 La Place Ct, Suite 100
Carlsbad, CA 92008 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
GenMark Diagnostics, Incorporated
EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel2022-04-27
GENMARK DIAGNOSTICS, INC.
ePlex KT0217912019-08-30
GENMARK DIAGNOSTICS, INC.
ePlex EA0030122019-08-30
GENMARK DIAGNOSTICS, INC.
ePlex EA0020122019-08-30
GENMARK DIAGNOSTICS, INC.
ePlex KT0218362019-08-30
GENMARK DIAGNOSTICS, INC.
ePlex EA0050122019-08-30
GENMARK DIAGNOSTICS, INC.
ePlex KT0222792019-08-30
GENMARK DIAGNOSTICS, INC.
ePlex System EA0010122019-08-23
GENMARK DIAGNOSTICS, INC.
ePlex System KT0220062019-08-23
GENMARK DIAGNOSTICS, INC.
ePlex System KT0222872019-08-23
GENMARK DIAGNOSTICS, INC.
ePlex 2019-08-23
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel2019-05-30
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel2019-05-30
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel2019-05-30
GenMark Diagnostics, Incorporated
EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel2019-04-12
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel2019-03-07
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel2019-03-07
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel2019-03-07
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel2019-03-07
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel2019-03-07
GENMARK DIAGNOSTICS, INC.
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel2019-03-07
GenMark Diagnostics, Incorporated
EPlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel2018-12-21
GenMark Diagnostics, Incorporated
EPlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel2018-12-20
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020012018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020012018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020012018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0040082018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0040082018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0040082018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0040132018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 KT0210532018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020142018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020142018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020142018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020152018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 KT0206572018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0051012018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0051012018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0051012018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0051002018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 KT0216202018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 MT0020002018-03-29
GENMARK DIAGNOSTICS, INC.
eSensor® XT-8 KT0205912018-03-29
GENMARK DIAGNOSTICS, INC.
GenMark ePlex Instrument2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Pathogen (RP) Panel2017-06-15
GenMark Diagnostics, Incorporated
EPlex Instrument2017-06-09
GENMARK DIAGNOSTICS, INCORPORATED
EPlex Respiratory Pathogen Panel2017-06-09
GENMARK DIAGNOSTICS, INCORPORATED
ESensor Warfarin Sensitivity Saliva Test2016-05-26
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC.
eSensor Respiratory Viral Panel Test2013-06-10
GENMARK DIAGNOSTICS, INC
ESENSOR WARFARIN SENSITIVITY SALIVA TEST2011-12-02
GENMARK DIAGNOSTICS, INC.
eSensor? XT-8 Instrument (System)2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? Thrombophilia Risk Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? MTHFR Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV-MTHFR Genotyping Te2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? XT-8 Instrument (System)2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? Thrombophilia Risk Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? MTHFR Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV-MTHFR Genotyping Te2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? XT-8 Instrument (System)2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? Thrombophilia Risk Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? MTHFR Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV-MTHFR Genotyping Te2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? XT-8 Instrument (System)2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? Thrombophilia Risk Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? MTHFR Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV-MTHFR Genotyping Te2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII-FV Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor? FII Genotyping Test2010-05-28
GENMARK DIAGNOSTICS, INC.
eSensor XT-8 System2009-12-18
GENMARK DIAGNOSTICS, INC.
eSensor CF Genotyping Test2009-12-18
GENMARK DIAGNOSTICS, INC.
eSensor XT-8 System2009-12-18
GENMARK DIAGNOSTICS, INC.
eSensor CF Genotyping Test2009-12-18
GENMARK DIAGNOSTICS, INC.
eSensor XT-8 System2008-08-15
GENMARK DIAGNOSTICS, INC.
eSensor Warfarin Sensitivity Test2008-08-15
GENMARK DIAGNOSTICS, INC.
eSensor XT-8 System2008-08-15
GENMARK DIAGNOSTICS, INC.
eSensor Warfarin Sensitivity Test2008-08-15
GENMARK DIAGNOSTICS, INC.
eSensor XT-8 System2008-08-15
GENMARK DIAGNOSTICS, INC.
eSensor Warfarin Sensitivity Test2008-08-15
GENMARK DIAGNOSTICS, INC.
Cystic Fibrosis Genotyping Test2007-12-28

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020070168165Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING9 PKG
2020030530319Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING8 PKG
2020030430767Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING8 PKG
2019112755542Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING320 BOX
2019062753256Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING348 BOX
2019062673601Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING348 BOX
2019022240652Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING8 BOX
2018111021870Caldera,Costa Rica -> Los Angeles, CaliforniaSILICON TUBING8 BOX

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