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    FDA Registration Active 🇺🇸 United States

    Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM (5N23-01)

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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

    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
    Cytomegalovirus (Cmv) Dna Quantitative Assay PAB

    Proprietary Names

    Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM (5N23-01) Abbott RealTime CMV Amplification Reagent Kit (5N23-90) Abbott RealTime CMV/EBV maxCycle with Aplification Extended Use (9N04-050) Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM)5N23-02) Abbott RealTime CMV Control Kit (5N23-80) Abbott RealTime CMV m2000 System ROW Combined Application CD-Rom Ver 3(5N23-03) Abbott RealTime CMV Calibrator Kit (5N23-70) Alinity m CMV Application Specification File (Whole Blood) 09N46-03B Alinity m CMV Application Specification File (Plasma) Alinity m CMV Amplification Reagent Kit 09N46-90 Alinity m CMV Control Kit 09N46-80 Alinity m CMV Calibration Kit 09N46-70 Alinity m CMV WB CAL Kit (09N46-072) Alinity m CMV WB CTRL Kit (09N46-082) Alinity m CMV WB AMP Kit (09N46-092) Alinity m CMV WB Application Specification File 09N46-07A

    Establishment Types

    Manufacture Device in the United States for Export Only