BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASI RPR CARD TEST FOR SYPHILIS

    Reg #: 1641328 · FEI: 1641328 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    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
    K851504

    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
    Antisera, Control For Nontreponemal Tests GMP

    Proprietary Names

    ASI RPR CARD TEST FOR SYPHILIS Sure-Vue Signature Raplid Plasma Reagin (RPR) Test Kit Cardinal Health RPR Card Test for Syphilis

    Establishment Types

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