BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott RealTime HIV-1 Control Kit

    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

    Regulatory Submissions

    PMA Number
    BP060002

    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
    Test, Hiv Detection MZF

    Proprietary Names

    Abbott RealTime HIV-1 Control Kit Abbott RealTime HIV-1 Abbott RealTime HIV-1 CD ROM 06L83 HIV-1 UNG Extended Use 06L18-067, 6L87-02 Abbott RealTime HIV-1 Control Kit 06L18-080 Abbott RealTime HIV-1 Including UNG 06L18-066, 6L87-02 Abbott RealTime HIV-1 Extended Use 06L18-050 Abbott RealTime HIV-1 Amplification Reagent Kit 06L18-090 Abbott RealTime HIV-1 Calibrator Kit 06L18-070 Abbott RealTime HIV-1 Calibrator Kit Amplification Reagent Kit

    Establishment Types

    Manufacture Medical Device