BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VENTANA HER2 (CAL27) Assay

    DI: 07613336234365 · Model: 10365005001 · Ventana Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    VENTANA HER2 (CAL27) Assay
    Primary DI
    07613336234365
    Version / Model
    10365005001
    Catalog Number
    10365005001
    Company Name
    Ventana Medical Systems, Inc.
    Labeler DUNS
    184042521
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-21
    Public Version
    1
    Public Version Date
    2025-10-29
    Public Version Status
    New
    Public Device Record Key
    bc1fa38b-12ec-4dcc-9448-26d53041a14a

    Device Characteristics

    Single Use
    No
    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
    NJT IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

    GMDN Terms

    Code Name
    57047 Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

    Identifiers

    Type ID
    Primary 07613336234365