BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trinity Biotech

    DI: 05391516748711 · Model: 40-5020M · MARDX DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trinity Biotech
    Primary DI
    05391516748711
    Version / Model
    40-5020M
    Catalog Number
    40-5020M
    Company Name
    MARDX DIAGNOSTICS, INC.
    Labeler DUNS
    154281349
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-18
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    ae8caee8-adb3-4ed2-aadb-224fc592a03a

    Device Description

    T. Pallidum IgM Marblot Strip Test System, Western Blot System for the detection of IgM antibody to T. pallidum, 20 Tests

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    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

    Product Codes

    Code Name
    JWL Antigen, Treponema Pallidum For Fta-Abs Test

    GMDN Terms

    Code Name
    51810 Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 05391516748711

    Customer Contacts

    Phone
    800-325-3424
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius