BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OnSite HIV 1/2 Ab Plus Combo Rapid Test (REF# R0011C)

    Reg #: 2032682 · FEI: 3003952975 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CTK BIOTECH, INC.
    Registration Number
    2032682
    FEI Number
    3003952975
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    13855 Stowe Dr
    City
    Poway
    State
    CA
    ZIP
    92064
    Country
    US

    Owner / Operator

    Firm Name
    CTK BIOTECH, INC.
    Operator Number
    9051784
    Address
    13855 Stowe Dr., --
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US

    Products

    Device Name Product Code
    Test, Hiv Detection MZF

    Proprietary Names

    OnSite HIV 1/2 Ab Plus Combo Rapid Test (REF# R0011C) OnSite HIV Ag/Ab 4th Gen Rapid Test (REF# R0018C) OnSite HIV/Syphilis/HBV/HCV Panel Rapid Test (REF# R0038C) OnSite HIV/Syphilis Ab Combo Rapid Test (REF# R0035C) RecombiLISA HIV 1+2 Ab ELISA (REF# E0410) RecombiLISA HIV 1+2 Ag-Ab ELISA (REF# E0420)

    Establishment Types

    Manufacture Device in the United States for Export Only