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    FDA Registration Active 🇺🇸 United States

    Alinity m HIV-1 Application Specification File for DBS Supplement v2

    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

    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

    Alinity m HIV-1 Application Specification File for DBS Supplement v2 Abbott RealTime HIV-1 HIV-1/HCV maxCycle CD ROM (03N23) HIV-1 CD-ROM (01L68) Abbott mSample Preparation System DBS Buffer Kit Abbott RealTime HIV-1 Qualitative CD-Rom m2000 System 13mm DBS PoSt Set Abbott RealTime HIV-1 Amplification Reagent Kit Alinity m Specimen Dilution Kit Alinity m HIV-1 Application Specification File Alinity m HIV-1 Amplification Kit, Alinity m HIV-1 Control Kit, Alinity m HIV-1 Calibrator Kit Dried Blood Spot (DBS) Supplement v2 to the Alinity m HIV-1 Assay (LN 08N45-040)

    Establishment Types

    Manufacture Device in the United States for Export Only