BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ABX PENTRA PREALBUMIN

    DI: 03610230005347 · Model: 1220001695 · HORIBA ABX SAS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ABX PENTRA PREALBUMIN
    Primary DI
    03610230005347
    Version / Model
    1220001695
    Company Name
    HORIBA ABX SAS
    Labeler DUNS
    273647420
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-16
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2c87bb51-295d-412c-a1ef-b297e3aa2179

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    JZJ Prealbumin, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53957 Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 03610230005347