BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    dIFine Automated Microscope

    Reg #: 3026753391 · FEI: 3026753391 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VISIA LAB SRL
    Registration Number
    3026753391
    FEI Number
    3026753391
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA MARTIRI DELLA LIBERTA 95/D
    City
    SAN GIOVANNI VALDARNO Arezzo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K201956

    Owner / Operator

    Firm Name
    VISIA LAB SRL
    Operator Number
    10085668
    Address
    VIA MARTIRI DELLA LIBERTA 95/D
    City
    SAN GIOVANNI VALDARNO
    State
    Arezzo
    Postal Code
    52027
    Country
    IT
    Correspondent
    Silvia Fantechi

    US Agent

    Business Name
    THEMA CORP
    Contact Name
    Silvia Tamarri
    Address
    2929 Arch Street
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US
    Email
    [email protected]
    Phone
    215 8459459

    Products

    Device Name Product Code
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN

    Proprietary Names

    dIFine Automated Microscope dIFine ANA HEp-2 Classifier

    Establishment Types

    Manufacture Medical Device