BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests

    DI: 05032384029594 · Model: TD0940A · OXOID LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests
    Primary DI
    05032384029594
    Version / Model
    TD0940A
    Company Name
    OXOID LIMITED
    Labeler DUNS
    365355452
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-11
    Public Version
    1
    Public Version Date
    2024-06-19
    Public Version Status
    New
    Public Device Record Key
    15fc29dd-e26f-4127-8d12-4a755104c4f1

    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
    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

    Product Codes

    Code Name
    GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.

    GMDN Terms

    Code Name
    51671 Staphylococcus aureus TSST-1 toxin antigen IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 05032384029594

    Premarket Submissions

    Submission Number Supplement Number
    K855236 000