BEUDAMED
    FDA Registration Active 🇦🇷 Argentina

    Chagatest ELISA Recombinante v.3

    Reg #: 8040374 · FEI: 5864 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WIENER LABORATORIOS S.A.I.C.
    Registration Number
    8040374
    FEI Number
    5864
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2571 Maipu
    City
    ROSARIO Santa Fe
    Country
    AR

    Regulatory Submissions

    510(k) Number
    K023889

    Owner / Operator

    Firm Name
    WIENER LABORATORIOS S.A.I.C.
    Operator Number
    8040374
    Address
    RioBamba 2944
    City
    Rosario
    State
    AR-NOTA
    Postal Code
    2000
    Country
    AR

    US Agent

    Business Name
    REGISTRAR CORP
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    HAMPTON
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Enzyme Linked Immunosorbent Assay, T. Cruzi MIU

    Proprietary Names

    Chagatest ELISA Recombinante v.3

    Establishment Types

    Manufacture Medical Device