BEUDAMED
    FDA Registration Active 🇺🇸 United States

    One Step Saliva Alcohol Test Strip

    Reg #: 3007606081 · FEI: 3007606081 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WONDFO USA CO., LTD.
    Registration Number
    3007606081
    FEI Number
    3007606081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    890 Remington Blvd
    City
    Bolingbrook
    State
    IL
    ZIP
    60440
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111206

    Owner / Operator

    Firm Name
    Wondfo USA Co., Ltd.
    Operator Number
    10028951
    Address
    890 REMINGTON BLVD
    City
    Bolingbrook
    State
    IL
    Postal Code
    60440
    Country
    US
    Correspondent
    Kunyuan Mao

    Products

    Device Name Product Code
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC

    Proprietary Names

    One Step Saliva Alcohol Test Strip Teco Diagnostics Saliva Alcohol Test Express Diagnostics International, Incorporated Saliva Alcohol Test Alcosmart Saliva Alcohol Test One Step Alcohol Saliva Test PRIME SCREEN® Saliva Alcohol Test Strip

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198