BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STD TEST KIT - SYPHILIS One step rapid test

    Reg #: 3034284973 · FEI: 3034284973 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AITRI KWIVA INC
    Registration Number
    3034284973
    FEI Number
    3034284973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    105 S MADISON AVE RICHMOND, KY 40475
    City
    Richmond
    State
    KY
    ZIP
    40475
    Country
    US

    Regulatory Submissions

    510(k) Number
    K001525

    Owner / Operator

    Firm Name
    AITRI KWIVA Inc
    Operator Number
    10092058
    Address
    105 S MADISON AVE RICHMOND, KY 40475
    City
    Richmond
    State
    KY
    Postal Code
    40475
    Country
    US
    Correspondent
    Mengjun Yi

    Products

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

    Proprietary Names

    STD TEST KIT - SYPHILIS One step rapid test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)