BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Panbio™ COVID-19 Antigen Self-Test (Abbott Diagnostics Korea Inc.)

    Reg #: 3015883679 · FEI: 3015883679 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Diagnostics Korea Inc.
    Registration Number
    3015883679
    FEI Number
    3015883679
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    65, Borahagal-ro, Giheung-gu
    City
    Yongin-si Gyeonggi
    Country
    KR

    Owner / Operator

    Firm Name
    Abbott
    Operator Number
    9006731
    Address
    100 Abbott Park Road, Dept. RX51/J55/MS 6134
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    Abbott Laboratories
    Contact Name
    Erica Sethi
    Address
    100 Abbott Park Road, Dept. RX53/Bldg J55-3/6136
    City
    Abbott Park
    State
    IL
    ZIP
    60064
    Country
    US
    Email
    [email protected]
    Phone
    224 2142756

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device