BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASI Select Staph Test

    Reg #: 1641328 · FEI: 1641328 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ARLINGTON SCIENTIFIC, INC.
    Registration Number
    1641328
    FEI Number
    1641328
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1840 NORTH TECHNOLOGY DR.
    City
    SPRINGVILLE
    State
    UT
    ZIP
    84663
    Country
    US

    Regulatory Submissions

    510(k) Number
    K830783

    Owner / Operator

    Firm Name
    ARLINGTON SCIENTIFIC, INC.
    Operator Number
    1641328
    Address
    1840 NORTH TECHNOLOGY DR., --
    City
    Springville
    State
    UT
    Postal Code
    84663
    Country
    US
    Correspondent
    BENJAMIN D CARD

    Products

    Device Name Product Code
    Kit, Screening, Staphylococcus Aureus JWX

    Proprietary Names

    ASI Select Staph Test Sure-Vue Color Staph Test ASI Color Staph Test Sure-Vue Select Staph Test Biokit Select Staph Test Biokit Color Staph Test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device