BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IH-500

    DI: 07611969233786 · Model: 001510 · Bio-Rad Medical Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IH-500
    Primary DI
    07611969233786
    Version / Model
    001510
    Catalog Number
    001510
    Company Name
    Bio-Rad Medical Diagnostics GmbH
    Labeler DUNS
    312576506
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-05
    Public Version
    6
    Public Version Date
    2024-01-22
    Public Version Status
    Update
    Public Device Record Key
    702edeb7-5b88-43e9-9bbc-d750cb166f2a

    Device Description

    IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KSZ System, Test, Automated Blood Grouping And Antibody

    GMDN Terms

    Code Name
    57846 Immunohaematology/blood bank analyser IVD

    Identifiers

    Type ID
    Primary 07611969233786