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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tina-quant Antistreptolysin O

    DI: 04015630920860 · Model: 4489403190 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tina-quant Antistreptolysin O
    Primary DI
    04015630920860
    Version / Model
    4489403190
    Catalog Number
    4489403190
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-18
    Public Version
    1
    Public Version Date
    2021-01-26
    Public Version Status
    New
    Public Device Record Key
    d4506489-8fd1-48e4-aac8-be59c0755c7c

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    GTQ ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT

    GMDN Terms

    Code Name
    59055 Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 04015630920860