BEUDAMED
    FDA Registration Active 🇨🇳 China

    PRIME SCREEN® Saliva Alcohol Test Strip

    Reg #: 3023322455 · FEI: 3023322455 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Registration Number
    3023322455
    FEI Number
    3023322455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 268, Shenzhou Road, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K111206

    Owner / Operator

    Firm Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Operator Number
    9064561
    Address
    No.8 lizhishan Road, Science City, Huangpu District, 510663
    City
    GUANGZHOU
    State
    Guangdong
    Postal Code
    510663
    Country
    CN
    Correspondent
    Jihua - Wang

    US Agent

    Business Name
    LSI International Inc.
    Contact Name
    Joe Shia
    Address
    504 East Diamond Ave., Suite I
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

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

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198