BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYPHILIS HEALTH CHECK

    Reg #: 3009178048 · FEI: 3009178048 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIAGNOSTICS DIRECT LLC
    Registration Number
    3009178048
    FEI Number
    3009178048
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    373 96th St Unit C
    City
    Stone Harbor
    State
    NJ
    ZIP
    08247
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102400

    Owner / Operator

    Firm Name
    Diagnostics Direct LLC
    Operator Number
    10037928
    Address
    359 96th Street, # 303
    City
    Stone Harbor
    State
    NJ
    Postal Code
    08247
    Country
    US
    Correspondent
    Norman Proulx

    Products

    Device Name Product Code
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP

    Proprietary Names

    SYPHILIS HEALTH CHECK

    Establishment Types

    Manufacture Medical Device