GENMARK DIAGNOSTICS, INC.

Address:GenMark Diagnostics, Inc.,Carlsbad,CA,92008,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Fungal Organisms, Nucleic Acid-Based Assay (PEO) (6) Gram-Negative Bacteria And Associated Resistance Markers (PEN) (6) Gram-Positive Bacteria And Their Resistance Markers (PAM) (6)

Premarket Exempt

Clear

eSensor® XT-8 - 00857167005238 Catalog Number : MT004008

Device Description : eSensor® Thrombophilia Risk Test Reagent Test Pack (TRT) (48)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005245 Catalog Number : MT002001

Device Description : eSensor® Warfarin Sensitivity Test Amplification Reagents (24)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005252 Catalog Number : MT002001

Device Description : eSensor® Warfarin Sensitivity Test Detection Reagents (WST) (24)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005276 Catalog Number : MT002001

Device Description : eSensor® Warfarin Sensitivity Test Reagent Pack (WST) (24)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

ePlex - 00857167005283 Catalog Number : KT022279

Device Description : ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : PEO, PEN, PAM

Prescription Use : Yes

Device Count : 1

ePlex - 00857167005290 Catalog Number : EA005012

Device Description : ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : PEO, PEN, PAM

Prescription Use : Yes

Device Count : 1

ePlex - 00857167005306 Catalog Number : KT021836

Device Description : ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : PEO, PEN, PAM

Prescription Use : Yes

Device Count : 1

ePlex - 00857167005313 Catalog Number : EA002012

Device Description : ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : PEO, PEN, PAM

Prescription Use : Yes

Device Count : 1

ePlex - 00857167005320 Catalog Number : EA003012

Device Description : ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : PEO, PEN, PAM

Prescription Use : Yes

Device Count : 1

ePlex - 00857167005337 Catalog Number : KT021791

Device Description : ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : PEO, PEN, PAM

Prescription Use : Yes

Device Count : 1

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