BEUDAMED
    FDA Registration Active 🇨🇳 China

    RightSign COVID-19 IgG/IgM Rapid Test Cassette

    Reg #: 3011522054 · FEI: 3011522054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Hangzhou Biotest Biotech Co.,Ltd.
    Registration Number
    3011522054
    FEI Number
    3011522054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17#,Futai Road,Zhongtai Street,Yuhang
    City
    Hangzhou Zhejiang
    Country
    CN

    Owner / Operator

    Firm Name
    Hangzhou Biotest Biotech Co.,Ltd.
    Operator Number
    10048622
    Address
    17#,Futai Road,Zhongtai Street,Yuhang
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311121
    Country
    CN
    Correspondent
    WADE WU

    US Agent

    Business Name
    Advin Biotech, Inc
    Contact Name
    Daniel Hsu
    Address
    10237 Flanders Ct, San Diego, CA 92121
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 8668382

    Products

    Device Name Product Code
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    RightSign COVID-19 IgG/IgM Rapid Test Cassette Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette CoronaCheck COVID-19 IgG/IgM Rapid Test Cassette

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device