BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott RealTime EBV Abbott RealTime EBV Calibrator Kit Abbott RealTime EBV m2000 System ROW Combined Application CDROM

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    Dna-Reagents, Epstein-Barr Virus LSF

    Proprietary Names

    Abbott RealTime EBV Abbott RealTime EBV Calibrator Kit Abbott RealTime EBV m2000 System ROW Combined Application CDROM Alinity m EBV Control Kit 09N43-80 Alinity m EBV Calibration Kit 09N43-70 Alinity m EBV Application Specification File 09N43-03A Alinity m EBV Amplification Reagent Kit 09N43-90 Alinity m EBV Amplification Reagent Kit 09N43-091 Alinity m EBV Application Specification File 09N43-07A Alinity m EBV WB CTRL Kit 09N43-082 Alinity m EBV WB Application Specification File 09N43-09A Alinity m EBV WB AMP Kit 09N43-092 Alinity m EBV WB CAL Kit 09N43-072

    Establishment Types

    Manufacture Device in the United States for Export Only