BEUDAMED
    FDA Registration Active 🇨🇳 China

    Test Yourself @ Home™ Immunochemical Fecal Occult Blood Test

    Reg #: 3004635103 · FEI: 3004635103 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Registration Number
    3004635103
    FEI Number
    3004635103
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.8 Lizhishan Road, Science City, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K162333

    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
    Reagent, Occult Blood KHE

    Proprietary Names

    Test Yourself @ Home™ Immunochemical Fecal Occult Blood Test Preview iFOB Immunochemical Fecal Occult Blood Test (FIT) Preview® iFOB Immunochemical Fecal Occult Blood Test COLONOX™ FIT EZCHECK® At-home iFOB Test Immunochemical Fecal Occult Blood Test(FIT) Wondfo One Step Fecal Occult Blood (FOB) Test 2SAN One Step Immunochemical Fecal Occult Blood Test (iFOB) COLONOX FIT Immunochemical Fecal Occult Blood Test INDICAID™ iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST RX INDICAID™ iFOB IMMUNOCHEMICAL FECAL OCCULT BLOOD RAPID TEST Aydmed Immunochemical Fecal Occult Blood (iFOB) Test

    Establishment Types

    Manufacture Medical Device