GENMARK DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008632402	3008632402	GENMARK DIAGNOSTICS, INC.	1	N	2026-01-01	GenMark Diagnostics, Inc. 5964 La Place Ct Carlsbad CA US 92008

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
124441	1448976184	K182690	ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel	PEO	2018-12-21
124441	1834710033	K182619	ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel	PEN	2019-04-12
124441	1611222550	K181663	ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel	PAM	2018-12-20
124441	1583691467	K163652	ePlex Instrument	NSU	2017-06-09
124441	1540655533	K163636	ePlex Respiratory Pathogen Panel	OCC	2017-06-09
124441	1700456215	K113731	ESENSOR RESPIRATORY VIRAL PANEL	JJH	2012-09-10
124441	1881176060	K093974	ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING	NPQ	2010-04-22
124441	1785392988	K090901	ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8	NUA	2009-07-06
124441	1753460919	K073720	ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT	ODW	2008-07-17
124441	1864557981	K060543	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800	NUA	2006-03-28
124441	1001469004
124441	1304920554

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NUA	2	2009-07-06
PEN	1	2019-04-12
PEO	1	2018-12-21
PAM	1	2018-12-20
NSU	1	2017-06-09
OCC	1	2017-06-09
JJH	1	2012-09-10
NPQ	1	2010-04-22
ODW	1	2008-07-17

PMN#

EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel
2022-04-27
GenMark Diagnostics, Incorporated
EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel
2019-04-12
GenMark Diagnostics, Incorporated
EPlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
2018-12-21
GenMark Diagnostics, Incorporated
EPlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
2018-12-20
GenMark Diagnostics, Incorporated
EPlex Instrument
2017-06-09
GenMark Diagnostics, Incorporated
EPlex Respiratory Pathogen Panel
2017-06-09
GENMARK DIAGNOSTICS, INCORPORATED
ESensor Warfarin Sensitivity Saliva Test
2016-05-26
GENMARK DIAGNOSTICS, INCORPORATED
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
2011-12-02
GENMARK DIAGNOSTICS, INC

GUDID#

ePlex - Instrumentation for clinical multiplex test systems
GENMARK DIAGNOSTICS, INC.
2018-05-21
ePlex System - ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
2018-01-03
ePlex System - ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
2017-12-29
eSensor® XT-8 - eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Respiratory Viral Panel Cartridges (RVP) (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Respiratory Viral Panel Amplification Reagents (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Respiratory Viral Panel Detection Reagents (RVP) (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Respiratory Viral Panel Reagent (RVP) (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Warfarin Sensitivity Test Cartridge Pouch (WST) (8)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Cystic Fibrosis Genotyping Test Cartridge Pouch (CF) (8)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Cystic Fibrosis Genotyping Test Amplification Reagents (CF) (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Cystic Fibrosis Genotyping Test Detection Reagents (CF) (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Cystic Fibrosis Genotyping Test Reagent Pack (CF) (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Thrombophilia Risk Test Cartridge Pouch (TRT) (8)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Thrombophilia Risk Test (TRT) (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Thrombophilia Risk Test Detection Reagents (TRT) (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Thrombophilia Risk Test Amplification Reagents (TRT) (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Thrombophilia Risk Test Reagent Test Pack (TRT) (48)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Warfarin Sensitivity Test Detection Reagents (WST) (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
eSensor® XT-8 - eSensor® Warfarin Sensitivity Test Reagent Pack (WST) (24)
GENMARK DIAGNOSTICS, INC.
2016-09-24
ePlex - ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch
GENMARK DIAGNOSTICS, INC.
2019-08-22
ePlex - ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box
GENMARK DIAGNOSTICS, INC.
2019-08-22
ePlex - ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch
GENMARK DIAGNOSTICS, INC.
2019-08-22
ePlex - ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box
GENMARK DIAGNOSTICS, INC.
2019-08-22
ePlex - ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch
GENMARK DIAGNOSTICS, INC.
2019-08-22
ePlex System - Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
2018-01-03
ePlex - ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box
GENMARK DIAGNOSTICS, INC.
2019-08-22