BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BinaxNOW COVID-19/Flu A&B

    Reg #: 3017662853 · FEI: 3017662853 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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

    Regulatory Submissions

    510(k) Number
    K243262

    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
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA

    Proprietary Names

    BinaxNOW COVID-19/Flu A&B BinaxNOW COVID-19/Flu A&B Combo Self Test

    Establishment Types

    Repack or Relabel Medical Device