BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WIESLAB Capture PR3 ANCA

    DI: 07340058410936 · Model: CapPR3 US · Euro-Diagnostica AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WIESLAB Capture PR3 ANCA
    Primary DI
    07340058410936
    Version / Model
    CapPR3 US
    Catalog Number
    CapPR3 US
    Company Name
    Euro-Diagnostica AB
    Labeler DUNS
    559894501
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    8505b011-cc01-4376-8614-11a1a3c63f98

    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

    Product Codes

    Code Name
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

    GMDN Terms

    Code Name
    55072 Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 07340058410936