BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas&#x00AE EBV/BKV Control Kit

    DI: 00875197006254 · Model: 08688214190 · 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 EBV/BKV Control Kit
    Primary DI
    00875197006254
    Version / Model
    08688214190
    Catalog Number
    08688214190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-10
    Public Version
    1
    Public Version Date
    2020-09-18
    Public Version Status
    New
    Public Device Record Key
    a466e4f7-f927-4a03-b941-64748d2b07d9

    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
    QLX Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA

    GMDN Terms

    Code Name
    61351 Multiple immunocompromised host infection-associated virus nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00875197006254