FDA.reportPublic FDA data

eSensor® XT-8

Primary DI
00857167005047
Brand
eSensor® XT-8
Company
GENMARK DIAGNOSTICS, INC.
Model
Warfarin Sensitivity Test (WST)
Catalog number
KT020591
Device description
eSensor® Warfarin Sensitivity Test Cartridge Pouch (WST) (8)
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857167005047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857167005047008571670050478571670050470857167005047

GMDN Terms#

Term, Definition table
TermDefinition
Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplexA collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose or predict gene polymorphisms within the Cytochrome P450 superfamily (CYP450) that are associated with metabolism of xenobiotics/drugs, including warfarin, analgesics and/or anti-depressants, using a multiplex method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962104217
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857167005009ePlexePlex System Base2018-05-21
00857167005023ePlex SystemePlex Respiratory Panel (RP)KT0220062018-01-03
00857167005030ePlex SystemePlex Respiratory Panel (RP)EA0010122017-12-29
00857167005092eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)KT0216202016-09-24
00857167005108eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051002016-09-24
00857167005115eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051012016-09-24
00857167005122eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051012016-09-24
00857167005139eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051012016-09-24
00857167005061eSensor® XT-8Warfarin Sensitivity Test (WST)MT0020002016-09-24
00857167005146eSensor® XT-8eSensor® Cystic Fibrosis (CF)KT0206572016-09-24
00857167005153eSensor® XT-8eSensor® Cystic Fibrosis (CF)MT0020152016-09-24
00857167005160eSensor® XT-8eSensor® Cystic Fibrosis (CF) MT0020142016-09-24
00857167005177eSensor® XT-8eSensor® Cystic Fibrosis (CF)MT0020142016-09-24
00857167005184eSensor® XT-8eSensor® Cystic Fibrosis (CF)MT0020142016-09-24
00857167005191eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)KT0210532016-09-24
00857167005207eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)MT0040132016-09-24
00857167005214eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)MT0040082016-09-24
00857167005221eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)MT0040082016-09-24
00857167005238eSensor® XT-8eSensor® Thrombophilia Risk Test Reagent Test (TRTMT0040082016-09-24
00857167005245eSensor® XT-8Warfarin Sensitivity Test (WST)MT0020012016-09-24