BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    eSensor® XT-8

    DI: 00857167005252 · Model: Warfarin Sensitivity Test (WST) · GENMARK DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    eSensor® XT-8
    Primary DI
    00857167005252
    Version / Model
    Warfarin Sensitivity Test (WST)
    Catalog Number
    MT002001
    Company Name
    GENMARK DIAGNOSTICS, INC.
    Labeler DUNS
    962104217
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2023-08-15
    Public Version Status
    Update
    Public Device Record Key
    c734e7c9-ddff-40ef-8828-e8e12dda7b9d
    Distribution End Date
    2023-08-14

    Device Description

    eSensor® Warfarin Sensitivity Test Detection Reagents (WST) (24)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    60519 Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 00857167005252