GENMARK DIAGNOSTICS, INC.

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

Want to know more about this Organization? Request more information now!

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

2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification (OQW) (3) Chlamydophila Pneumoniae Dna Assay System (OZY) (3) Human Metapneumovirus (Hmpv) Rna Assay System (OEM) (3) Influenza A And Influenza B Multiplex Nucleic Acid Assay (OZE) (3) Influenza A Virus Subtype Differentiation Nucleic Acid Assay (OEP) (3) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (3) Mycoplasma Pneumoniae Dna Assay System (OZX) (3) Non-Sars Coronavirus Multiplex Nucleic Acid Assay (OTG) (3) Parainfluenza Multiplex Nucleic Acid Assay (OOU) (3) Instrumentation For Clinical Multiplex Test Systems (NSU) (1)

Premarket Exempt

Clear

ePlex - 00857167005009 Catalog Number :

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

ePlex System - 00857167005016 Catalog Number : KT022287

Device Description : Respiratory Panel Cartridge

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : OZY, OZX, OZE, OTG, OQW, OOU, OEP, OEM, OCC

Prescription Use : Yes

Device Count : 1

ePlex System - 00857167005023 Catalog Number : KT022006

Device Description : ePlex Sample Delivery Device RP Panel

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : OZY, OZX, OZE, OTG, OQW, OOU, OEP, OEM, OCC

Prescription Use : Yes

Device Count : 1

ePlex System - 00857167005030 Catalog Number : EA001012

Device Description : ePlex Respiratory Panel Kit, 12 test, IVD

Device Class : 2

Duns Number: 962104217

Premarket Exempt : No

Product Code : OZY, OZX, OZE, OTG, OQW, OOU, OEP, OEM, OCC

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005047 Catalog Number : KT020591

Device Description : eSensor® Warfarin Sensitivity Test Cartridge Pouch (WST) (8)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005061 Catalog Number : MT002000

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

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005092 Catalog Number : KT021620

Device Description : eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005108 Catalog Number : MT005100

Device Description : eSensor® Respiratory Viral Panel Cartridges (RVP) (48)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005115 Catalog Number : MT005101

Device Description : eSensor® Respiratory Viral Panel Amplification Reagents (48)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

eSensor® XT-8 - 00857167005122 Catalog Number : MT005101

Device Description : eSensor® Respiratory Viral Panel Detection Reagents (RVP) (48)

Device Class :

Duns Number: 962104217

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 Next