BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas&#x00AE vivoDx MRSA Collection and Transport Kit

    DI: 00875197005813 · Model: 08064776190 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas&#x00AE vivoDx MRSA Collection and Transport Kit
    Primary DI
    00875197005813
    Version / Model
    08064776190
    Catalog Number
    08064776190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-15
    Public Version
    1
    Public Version Date
    2020-01-23
    Public Version Status
    New
    Public Device Record Key
    9eeb3f7f-5b8c-4546-8bb4-0eee4a1d69ee

    Device Characteristics

    Single Use
    Yes
    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
    QIV Culture-based short-term incubation antimicrobial resistance assay

    GMDN Terms

    Code Name
    64569 MRSA phenotype detection IVD, kit, bioassay

    Identifiers

    Type ID
    Primary 00875197005813

    Premarket Submissions

    Submission Number Supplement Number
    DEN190016 000