BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UROVYSION BLADDER C ANCER KIT

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABBOTT MOLECULAR, INC.
    Registration Number
    3005248192
    FEI Number
    3005248192
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1300 EAST TOUHY AVENUE
    City
    Des Plaines
    State
    IL
    ZIP
    60018
    Country
    US

    Regulatory Submissions

    PMA Number
    P030052

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence NSD

    Proprietary Names

    UROVYSION BLADDER C ANCER KIT ProbeChek Slides 02J27-011 UroVysion Bladder Cancer Kit, 100 Assay 02J27-095 UroVysion Bladder Cancer Kit, 20 Assay 02J27-025

    Establishment Types

    Manufacture Medical Device