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    FDA Registration Active 🇺🇸 United States

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

    Reg #: 3017662853 · FEI: 3017662853 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Diagnostics Scarborough, Inc.
    Registration Number
    3017662853
    FEI Number
    3017662853
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Bradley Drive
    City
    Westbrook
    State
    ME
    ZIP
    04092
    Country
    US

    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

    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