BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys Anti-HCV II

    DI: 07613336183052 · Model: 08837058162 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    16

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    Basic Information

    Brand Name
    Elecsys Anti-HCV II
    Primary DI
    07613336183052
    Version / Model
    08837058162
    Catalog Number
    08837058162
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    16
    Record Status
    Published
    Publish Date
    2025-02-18
    Public Version
    1
    Public Version Date
    2025-02-26
    Public Version Status
    New
    Public Device Record Key
    2db29ee6-9746-47da-a61d-b2c3dc0c25ea

    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
    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
    QHM Serology tests used for infectious disease screening of blood and plasma donations

    GMDN Terms

    Code Name
    48366 Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

    Identifiers

    Type ID
    Unit of Use 07613336228432
    Primary 07613336183052