BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BinaxNOW Malaria Positive Control

    Reg #: 3017662853 · FEI: 3017662853 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K083744

    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
    Kit, Direct Antigen, Positive Control MJZ

    Proprietary Names

    BinaxNOW Malaria Positive Control

    Establishment Types

    Manufacture Medical Device