eSensor® XT-8 MT002015

GUDID 00857167005153

eSensor® Cystic Fibrosis (CF) Genotyping Test (24)

GENMARK DIAGNOSTICS, INC.

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Primary Device ID00857167005153
NIH Device Record Key9c60e621-39b5-46b1-8cf2-334629356ca5
Commercial Distribution StatusIn Commercial Distribution
Brand NameeSensor® XT-8
Version Model NumbereSensor® Cystic Fibrosis (CF)
Catalog NumberMT002015
Company DUNS962104217
Company NameGENMARK DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857167005153 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [eSensor® XT-8]

00857167005276eSensor® Warfarin Sensitivity Test Reagent Pack (WST) (24)
00857167005252eSensor® Warfarin Sensitivity Test Detection Reagents (WST) (24)
00857167005245eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
00857167005238eSensor® Thrombophilia Risk Test Reagent Test Pack (TRT) (48)
00857167005221eSensor® Thrombophilia Risk Test Amplification Reagents (TRT) (48)
00857167005214eSensor® Thrombophilia Risk Test Detection Reagents (TRT) (48)
00857167005207eSensor® Thrombophilia Risk Test (TRT) (48)
00857167005191eSensor® Thrombophilia Risk Test Cartridge Pouch (TRT) (8)
00857167005184eSensor® Cystic Fibrosis Genotyping Test Reagent Pack (CF) (24)
00857167005177eSensor® Cystic Fibrosis Genotyping Test Detection Reagents (CF) (24)
00857167005160eSensor® Cystic Fibrosis Genotyping Test Amplification Reagents (CF) (24)
00857167005153eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
00857167005146eSensor® Cystic Fibrosis Genotyping Test Cartridge Pouch (CF) (8)
00857167005139eSensor® Respiratory Viral Panel Reagent (RVP) (48)
00857167005122eSensor® Respiratory Viral Panel Detection Reagents (RVP) (48)
00857167005115eSensor® Respiratory Viral Panel Amplification Reagents (48)
00857167005108eSensor® Respiratory Viral Panel Cartridges (RVP) (48)
00857167005092eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)
00857167005061eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
00857167005047eSensor® Warfarin Sensitivity Test Cartridge Pouch (WST) (8)

Trademark Results [eSensor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESENSOR
ESENSOR
86718185 not registered Dead/Abandoned
GenMark Diagnostics, Inc.
2015-08-07
ESENSOR
ESENSOR
85070811 3914394 Live/Registered
GenMark Diagnostics, Inc.
2010-06-24
ESENSOR
ESENSOR
76020415 2948306 Live/Registered
GENMARK DIAGNOSTICS, INC.
2000-04-06

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