BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott RealTime HCV Calibration Kit 01N30-070

    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
    P100017

    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
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus MZP

    Proprietary Names

    Abbott RealTime HCV Calibration Kit 01N30-070 Abbott RealTime HCV CD-ROM 04N45 Abbott RealTime HCV Amplification Kit including UNG 01N30-66, 6L87-02 Abbott RealTime HCV Control Kit 01N30-80 Abbott RealTime HCV UNG Extended Use 01N30-067 Abbott RealTime HCV Amplification Kit 01N30-090 Abbott RealTime HCV

    Establishment Types

    Manufacture Medical Device