BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ALBAclone Anti-D fusion

    DI: 05060242471797 · Model: Z043U · ALBA BIOSCIENCE LIMITED
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ALBAclone Anti-D fusion
    Primary DI
    05060242471797
    Version / Model
    Z043U
    Company Name
    ALBA BIOSCIENCE LIMITED
    Labeler DUNS
    516536641
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-24
    Public Version
    3
    Public Version Date
    2022-03-31
    Public Version Status
    Update
    Public Device Record Key
    97c6faf4-9e3f-47a5-8016-5e4797ed1ea9

    Device Description

    This Anti-D reagent is for the in vitro detection and identification of human RhD blood group status in patient and donor samples by direct agglutination and the indirect antiglobulin test.

    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
    52647 Anti-Rh(D) red blood cell grouping IVD, antibody

    Identifiers

    Type ID
    Package 05060242471827
    Primary 05060242471797
    Package 05060242471810
    Package 05060242471803

    Customer Contacts

    Phone
    +41225458274
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius