BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vysis ALK Break Apart FISH Probve Kit

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    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
    P110012

    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
    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement OWE

    Proprietary Names

    Vysis ALK Break Apart FISH Probve Kit ProbeCheck ALK Positive Control Slides ProbeCheck ALK Negative Control Slides 06N38-005 Vysis ALK Break Apart FISH Probe Kit (06N38-053) Vysis Paraffin Pretreatment IV and Post Hybridization Wash Buffer Kit 01N31-005 ProbeCheck ALK Positive Control Slides 06N38-010 Vysis ALK Break Apart FISH Probe Kit 06N38-020 Vysis ALK Break Apart FISH Probe Kit (06N38-033) VP2000 Pretreatment Kit (08N16-001) Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit ProbeCheck ALK Negative Control Slides

    Establishment Types

    Manufacture Medical Device