BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    eSensor® XT-8

    DI: 00857167005115 · Model: eSensor® Respiratory Viral Panel (RVP) · 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
    00857167005115
    Version / Model
    eSensor® Respiratory Viral Panel (RVP)
    Catalog Number
    MT005101
    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
    4
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    dcf72221-b3ab-496e-9133-14a1750ea0f2
    Distribution End Date
    2023-08-14

    Device Description

    eSensor® Respiratory Viral Panel Amplification Reagents (48)

    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
    48245 Multiple-genus respiratory virus antigen IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 00857167005115