BEUDAMED
    FDA Registration Active 🇨🇳 China

    Wondfo Biotech Co. Ltd WondView Strep A Test Kit

    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
    K133343

    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
    Antigens, All Groups, Streptococcus Spp. GTY

    Proprietary Names

    Wondfo Biotech Co. Ltd WondView Strep A Test Kit IMCO Strep A Rapid Test IMCO Strep A Rapid Test Strip One Step Strep A Swab Test Dealmed Medical Supplies Strep A Rapid Test Strips Easy Healthcare Corporation, Areta Strep A Swab Test SMC Direct LLC RefuAH Strep A Rapid Clarity Strep A Rapid Test Wondfo Biotech Co. Ltd Preview Strep A Test Kit Guangzhou Wondfo Biotech Co. Ltd Wondfo One Step Strep A Swab Test Clarity Strep A Rapid Test Strip

    Establishment Types

    Manufacture Medical Device