BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IH-Card Group ABO

    DI: 07611969962358 · Model: 813170100 · Bio-Rad Medical Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IH-Card Group ABO
    Primary DI
    07611969962358
    Version / Model
    813170100
    Catalog Number
    813170100
    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
    2017-01-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    d56c1b17-d056-4a68-8574-7dd334effb2c

    Device Description

    Gel card for use with the IH-system; Card for ABO antigen typing; 12 cards of 6 microtubes

    Device Characteristics

    Single Use
    Yes
    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

    GMDN Terms

    Code Name
    46442 Anti-AB red blood cell grouping IVD, antibody

    Identifiers

    Type ID
    Primary 07611969962358

    Customer Contacts

    Phone
    800-224-6723
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Upright position
    Type
    Storage Environment Temperature
    Temperature Range
    18 – 25 Degrees Celsius