BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas&#x00AE EZH2 Mutation Test

    DI: 00875197005592 · Model: 7258321190 · 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 EZH2 Mutation Test
    Primary DI
    00875197005592
    Version / Model
    7258321190
    Catalog Number
    07258321190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-01
    Public Version
    1
    Public Version Date
    2020-08-10
    Public Version Status
    New
    Public Device Record Key
    1caf27c9-7d57-4d3b-8632-af46f385e636

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OWD Somatic gene mutation detection system

    GMDN Terms

    Code Name
    64643 Enhancer of zeste homolog 2 (EZH2) gene mutation IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00875197005592