BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZEUS IFA™ ANA HEp-2 Test System

    Reg #: 2242436 · FEI: 2242436 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ZEUS SCIENTIFIC
    Registration Number
    2242436
    FEI Number
    2242436
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 EVANS WAY
    City
    BRANCHBURG
    State
    NJ
    ZIP
    08876
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201956

    Owner / Operator

    Firm Name
    ZEUS SCIENTIFIC
    Operator Number
    2242436
    Address
    200 EVANS WAY, --
    City
    Branchburg
    State
    NJ
    Postal Code
    08876
    Country
    US

    Products

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

    Proprietary Names

    ZEUS IFA™ ANA HEp-2 Test System ZEUS dIFine® Digital Scanner and Software

    Establishment Types

    Manufacture Medical Device