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.

USA

NASDAQ

GNMK

DUNS 962104217

FDA Registration(s)

• Registration Number: 3008632402
• FEI Number: 3008632402
• Name: GENMARK DIAGNOSTICS, INC.
• Owner & Operator: GenMark Diagnostics, Inc.
• Contact Address: GenMark Diagnostics, Inc. 5964 La Place Ct, Suite 100; Carlsbad CA 92008 US
• Official Correspondent:
  • Alan B Maderazo
  • x-760-4484308-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: GenMark 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	Device	Date
PMN K213236 GenMark Diagnostics, Incorporated	EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel	2022-04-27
GUDID 00857167005337 GENMARK DIAGNOSTICS, INC.	ePlex KT021791	2019-08-30
GUDID 00857167005320 GENMARK DIAGNOSTICS, INC.	ePlex EA003012	2019-08-30
GUDID 00857167005313 GENMARK DIAGNOSTICS, INC.	ePlex EA002012	2019-08-30
GUDID 00857167005306 GENMARK DIAGNOSTICS, INC.	ePlex KT021836	2019-08-30
GUDID 00857167005290 GENMARK DIAGNOSTICS, INC.	ePlex EA005012	2019-08-30
GUDID 00857167005283 GENMARK DIAGNOSTICS, INC.	ePlex KT022279	2019-08-30
GUDID 00857167005030 GENMARK DIAGNOSTICS, INC.	ePlex System EA001012	2019-08-23
GUDID 00857167005023 GENMARK DIAGNOSTICS, INC.	ePlex System KT022006	2019-08-23
GUDID 00857167005016 GENMARK DIAGNOSTICS, INC.	ePlex System KT022287	2019-08-23
GUDID 00857167005009 GENMARK DIAGNOSTICS, INC.	ePlex	2019-08-23
PMN K182619 | PEO GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	2019-05-30
PMN K182619 | PEN GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	2019-05-30
PMN K182619 | PAM GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	2019-05-30
PMN K182619 GenMark Diagnostics, Incorporated	EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel	2019-04-12
PMN K182690 | PEO GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel	2019-03-07
PMN K182690 | PEN GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel	2019-03-07
PMN K182690 | PAM GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel	2019-03-07
PMN K181663 | PEO GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	2019-03-07
PMN K181663 | PEN GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	2019-03-07
PMN K181663 | PAM GENMARK DIAGNOSTICS, INC.	ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	2019-03-07
PMN K182690 GenMark Diagnostics, Incorporated	EPlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel	2018-12-21
PMN K181663 GenMark Diagnostics, Incorporated	EPlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	2018-12-20
GUDID 00857167005276 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002001	2018-03-29
GUDID 00857167005252 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002001	2018-03-29
GUDID 00857167005245 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002001	2018-03-29
GUDID 00857167005238 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT004008	2018-03-29
GUDID 00857167005221 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT004008	2018-03-29
GUDID 00857167005214 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT004008	2018-03-29
GUDID 00857167005207 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT004013	2018-03-29
GUDID 00857167005191 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 KT021053	2018-03-29
GUDID 00857167005184 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002014	2018-03-29
GUDID 00857167005177 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002014	2018-03-29
GUDID 00857167005160 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002014	2018-03-29
GUDID 00857167005153 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002015	2018-03-29
GUDID 00857167005146 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 KT020657	2018-03-29
GUDID 00857167005139 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT005101	2018-03-29
GUDID 00857167005122 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT005101	2018-03-29
GUDID 00857167005115 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT005101	2018-03-29
GUDID 00857167005108 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT005100	2018-03-29
GUDID 00857167005092 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 KT021620	2018-03-29
GUDID 00857167005061 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 MT002000	2018-03-29
GUDID 00857167005047 GENMARK DIAGNOSTICS, INC.	eSensor® XT-8 KT020591	2018-03-29
PMN K163652 | NSU GENMARK DIAGNOSTICS, INC.	GenMark ePlex Instrument	2017-06-15
PMN K163636 | OZY GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OZX GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OZE GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OTG GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OQW GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OOU GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OEP GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OEM GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | OCC GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163636 | NSU GENMARK DIAGNOSTICS, INC.	ePlex Respiratory Pathogen (RP) Panel	2017-06-15
PMN K163652 GenMark Diagnostics, Incorporated	EPlex Instrument	2017-06-09
PMN K163636 GENMARK DIAGNOSTICS, INCORPORATED	EPlex Respiratory Pathogen Panel	2017-06-09
PMN K152612 GENMARK DIAGNOSTICS, INCORPORATED	ESensor Warfarin Sensitivity Saliva Test	2016-05-26
PMN K113731 | OUL GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K113731 | OQW GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K113731 | OOU GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K113731 | OEP GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K113731 | OEM GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K113731 | OCC GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K113731 | NSU GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K113731 | JJH GENMARK DIAGNOSTICS, INC.	eSensor Respiratory Viral Panel Test	2013-06-10
PMN K110786 GENMARK DIAGNOSTICS, INC	ESENSOR WARFARIN SENSITIVITY SALIVA TEST	2011-12-02
PMN K093974 | OMM GENMARK DIAGNOSTICS, INC.	eSensor? XT-8 Instrument (System)	2010-05-28
PMN K093974 | OMM GENMARK DIAGNOSTICS, INC.	eSensor? Thrombophilia Risk Test	2010-05-28
PMN K093974 | OMM GENMARK DIAGNOSTICS, INC.	eSensor? MTHFR Genotyping Test	2010-05-28
PMN K093974 | OMM GENMARK DIAGNOSTICS, INC.	eSensor? FV Genotyping Test	2010-05-28
PMN K093974 | OMM GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV-MTHFR Genotyping Te	2010-05-28
PMN K093974 | OMM GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV Genotyping Test	2010-05-28
PMN K093974 | OMM GENMARK DIAGNOSTICS, INC.	eSensor? FII Genotyping Test	2010-05-28
PMN K093974 | NSU GENMARK DIAGNOSTICS, INC.	eSensor? XT-8 Instrument (System)	2010-05-28
PMN K093974 | NSU GENMARK DIAGNOSTICS, INC.	eSensor? Thrombophilia Risk Test	2010-05-28
PMN K093974 | NSU GENMARK DIAGNOSTICS, INC.	eSensor? MTHFR Genotyping Test	2010-05-28
PMN K093974 | NSU GENMARK DIAGNOSTICS, INC.	eSensor? FV Genotyping Test	2010-05-28
PMN K093974 | NSU GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV-MTHFR Genotyping Te	2010-05-28
PMN K093974 | NSU GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV Genotyping Test	2010-05-28
PMN K093974 | NSU GENMARK DIAGNOSTICS, INC.	eSensor? FII Genotyping Test	2010-05-28
PMN K093974 | NPR GENMARK DIAGNOSTICS, INC.	eSensor? XT-8 Instrument (System)	2010-05-28
PMN K093974 | NPR GENMARK DIAGNOSTICS, INC.	eSensor? Thrombophilia Risk Test	2010-05-28
PMN K093974 | NPR GENMARK DIAGNOSTICS, INC.	eSensor? MTHFR Genotyping Test	2010-05-28
PMN K093974 | NPR GENMARK DIAGNOSTICS, INC.	eSensor? FV Genotyping Test	2010-05-28
PMN K093974 | NPR GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV-MTHFR Genotyping Te	2010-05-28
PMN K093974 | NPR GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV Genotyping Test	2010-05-28
PMN K093974 | NPR GENMARK DIAGNOSTICS, INC.	eSensor? FII Genotyping Test	2010-05-28
PMN K093974 | NPQ GENMARK DIAGNOSTICS, INC.	eSensor? XT-8 Instrument (System)	2010-05-28
PMN K093974 | NPQ GENMARK DIAGNOSTICS, INC.	eSensor? Thrombophilia Risk Test	2010-05-28
PMN K093974 | NPQ GENMARK DIAGNOSTICS, INC.	eSensor? MTHFR Genotyping Test	2010-05-28
PMN K093974 | NPQ GENMARK DIAGNOSTICS, INC.	eSensor? FV Genotyping Test	2010-05-28
PMN K093974 | NPQ GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV-MTHFR Genotyping Te	2010-05-28
PMN K093974 | NPQ GENMARK DIAGNOSTICS, INC.	eSensor? FII-FV Genotyping Test	2010-05-28
PMN K093974 | NPQ GENMARK DIAGNOSTICS, INC.	eSensor? FII Genotyping Test	2010-05-28
PMN K090901 | NUA GENMARK DIAGNOSTICS, INC.	eSensor XT-8 System	2009-12-18
PMN K090901 | NUA GENMARK DIAGNOSTICS, INC.	eSensor CF Genotyping Test	2009-12-18
PMN K090901 | NSU GENMARK DIAGNOSTICS, INC.	eSensor XT-8 System	2009-12-18
PMN K090901 | NSU GENMARK DIAGNOSTICS, INC.	eSensor CF Genotyping Test	2009-12-18
PMN K073720 | ODW GENMARK DIAGNOSTICS, INC.	eSensor XT-8 System	2008-08-15
PMN K073720 | ODW GENMARK DIAGNOSTICS, INC.	eSensor Warfarin Sensitivity Test	2008-08-15
PMN K073720 | ODV GENMARK DIAGNOSTICS, INC.	eSensor XT-8 System	2008-08-15
PMN K073720 | ODV GENMARK DIAGNOSTICS, INC.	eSensor Warfarin Sensitivity Test	2008-08-15
PMN K073720 | NSU GENMARK DIAGNOSTICS, INC.	eSensor XT-8 System	2008-08-15
PMN K073720 | NSU GENMARK DIAGNOSTICS, INC.	eSensor Warfarin Sensitivity Test	2008-08-15
PMN K060543 | NUA GENMARK DIAGNOSTICS, INC.	Cystic Fibrosis Genotyping Test	2007-12-28

Related Finance Registrations

NCAGE Code	6JBA4	GENMARK DIAGNOSTICS, INC.
CAGE Code	6JBA4	GENMARK DIAGNOSTICS, INC.
CAGE Code	6VLJ7	GENMARK DIAGNOSTICS, INC.
S.A.M. Registration	6JBA4 [962104217]	GENMARK DIAGNOSTICS, INC.
SEC	0001487371	GenMark Diagnostics, Inc. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020070168165	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	9 PKG
2020030530319	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	8 PKG
2020030430767	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	8 PKG
2019112755542	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	320 BOX
2019062753256	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	348 BOX
2019062673601	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	348 BOX
2019022240652	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	8 BOX
2018111021870	Caldera,Costa Rica -> Los Angeles, California	SILICON TUBING	8 BOX