BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biotrin Parvovirus B19 IgG EIA

    DI: EBTRV519IGUS02 · Model: V5191GUS · DIASORIN IRELAND LIMITED
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Biotrin Parvovirus B19 IgG EIA
    Primary DI
    EBTRV519IGUS02
    Version / Model
    V5191GUS
    Company Name
    DIASORIN IRELAND LIMITED
    Labeler DUNS
    988123139
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    226331a9-6227-44ab-a38d-afb275875a87

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    50157 Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary EBTRV519IGUS02