BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    SARS-CoV-2-IgG Reagent Kit (ARCHITECT, LN 6R86-20, 6R86-30)

    Reg #: 3005094123 · FEI: 3005094123 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Registration Number
    3005094123
    FEI Number
    3005094123
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lisnamuck
    City
    Longford
    Country
    IE

    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

    US Agent

    Business Name
    ABBOTT LABORATORIES
    Contact Name
    Sara Qadri
    Address
    675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US
    Email
    [email protected]
    Phone
    224 6680142

    Products

    Device Name Product Code
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    SARS-CoV-2-IgG Reagent Kit (ARCHITECT, LN 6R86-20, 6R86-30) AdviseDx SARS-CoV-2 IgM Control Kit (ARCHITECT, LN 06R8710) SARS-CoV-2 IgG Control Kit (Alinity i, LN 06R9010) SARS-CoV-2 IgG Calibrator Kit (ARCHITECT, LN 6R86-01) AdviseDx SARS-CoV-2 IgM Control Kit (Alinity i, LN 06R9110) AdviseDx SARS-CoV-2 IgM Reagent Kit (ARCHITECT, LN 06R8720, 06R8730) AdviseDx SARS-CoV-2 IgM Calibrator Kit (Alinity i, LN 06R9101) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (ARCHITECT, LN 6S60-01) AdviseDx SARS-CoV-2 IgM Reagent Kit (Alinity i, LN 06R9120, 06R9130) AdviseDx SARS-CoV-2 IgG II Control Kit (ARCHITECT, LN 6S60-10) AdviseDx SARS-CoV-2 IgG II (Alinity i, LN 06S6120, 06S6130) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (Alinity i, LN 06S6101) SARS-CoV-2 IgG Control Kit (ARCHITECT, LN 6R86-10) SARS-CoV-2 IgG Calibrator Kit (Alinity i, LN 06R9001) AdviseDx SARS-CoV-2 IgM Calibrator Kit (ARCHITECT, LN 06R8701) SARS-CoV-2 IgG Reagent Kit (Alinity i, LN 06R9020, 06R9030) AdviseDx SARS-CoV-2 IgG II (ARCHITECT, LN 6S60-20, 6S60-30) AdviseDx SARS-CoV-2 IgG II Control Kit (Alinity i, LN 06S6110)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)