BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PathoDxtra Strep Grouping Kit (60 tests)

    DI: 05032384519552 · Model: DR0700M · OXOID LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PathoDxtra Strep Grouping Kit (60 tests)
    Primary DI
    05032384519552
    Version / Model
    DR0700M
    Company Name
    OXOID LIMITED
    Labeler DUNS
    365355452
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-19
    Public Version
    1
    Public Version Date
    2024-06-27
    Public Version Status
    New
    Public Device Record Key
    ad8e54ec-e8ad-491e-bbc3-01558a46228c

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    GTZ Antisera, All Groups, Streptococcus Spp.

    GMDN Terms

    Code Name
    43586 Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 05032384519552