BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas® SARS-CoV-2 Qualitative 480T

    DI: 00875197006933 · Model: 09448870190 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas® SARS-CoV-2 Qualitative 480T
    Primary DI
    00875197006933
    Version / Model
    09448870190
    Catalog Number
    09448870190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-12
    Public Version
    1
    Public Version Date
    2023-09-20
    Public Version Status
    New
    Public Device Record Key
    8b3747a4-579c-44de-81eb-a536947fc6ca

    Device Characteristics

    Single Use
    No
    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

    Product Codes

    Code Name
    QQX Respiratory specimen nucleic acid SARS-CoV-2 test

    GMDN Terms

    Code Name
    64747 SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00875197006933