BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Abbott Diagnostics Korea Inc.

    Reg #: 3015883679 · FEI: 3015883679 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    Abbott Diagnostics Korea Inc.
    Registration Number
    3015883679
    FEI Number
    3015883679
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    65, Borahagal-ro, Giheung-gu
    City
    Yongin-si Gyeonggi
    Country
    KR

    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
    Alere Inc.
    Contact Name
    Anita Nosratieh
    Address
    150 S. Saunders Road, Landmark of Lake Forest
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US
    Email
    [email protected]
    Phone
    224 6670137

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

    BinaxNOW COVID-19 Antigen Self-Test (EUA210264) BinaxNOW COVID-19 Ag Card Home Test (EUA203107) BinaxNOW COVID-19 Ag Card (EUA202537) Panbio™ COVID-19 Antigen Self-Test (Abbott Diagnostics Korea Inc.) BinaxNOW COVID-19 Positive Control Swab Kit BinaxNOW COVID-19 Reagent Accessory Pack

    Establishment Types

    Manufacture Medical Device