BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PATHVYSION HER-2 20 ASSAY

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    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
    P980024

    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
    System, Test, Her-2/Neu, Nucleic Acid Or Serum MVD

    Proprietary Names

    PATHVYSION HER-2 20 ASSAY PATHVYSION HER-2 100 TEST PathVysion HER-2 50 Assay 02J01-035 PathVysion HER-2 100 Assay 02J01-036 PathVysion HER-2 20 Assay 02J01-030 ProbeCheck Slides 02J04-030, 02J05-030 PATHVYSION HER-2 50 ASSAY

    Establishment Types

    Manufacture Medical Device