BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ALBAclone Anti-Jka (Monoclonal)

    DI: 05060242472480 · Model: Z164U · ALBA BIOSCIENCE LIMITED
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ALBAclone Anti-Jka (Monoclonal)
    Primary DI
    05060242472480
    Version / Model
    Z164U
    Company Name
    ALBA BIOSCIENCE LIMITED
    Labeler DUNS
    516536641
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-01
    Public Version
    1
    Public Version Date
    2021-02-09
    Public Version Status
    New
    Public Device Record Key
    ca6ad588-71f6-428f-8164-d0a0d595dc3b

    Device Description

    This Anti-Jka reagent is for the in vitro detection and identification of the human Jka blood group antigen by direct agglutination.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    52586 Anti-Jk^a red blood cell grouping IVD, antibody

    Identifiers

    Type ID
    Package 05060242472497
    Primary 05060242472480
    Package 05060242472503