BEUDAMED
    FDA Registration Active 🇨🇳 China

    BIOTEKE CORPORATION (WUXI) CO., LTD

    Reg #: 3016837106 · FEI: 3016837106 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    21

    Registration Details

    Registration Name
    BIOTEKE CORPORATION (WUXI) CO., LTD
    Registration Number
    3016837106
    FEI Number
    3016837106
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 90, Huiming Road, Huishan
    City
    Wuxi City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K211707

    Owner / Operator

    Firm Name
    BioTeke Corporation (Wuxi) Co., Ltd
    Operator Number
    10071745
    Address
    4th floor, D5, No.1719,Huishan Avenue
    City
    Wuxi
    State
    Jiangsu
    Postal Code
    214174
    Country
    CN
    Correspondent
    Zhitu Zhou

    US Agent

    Business Name
    E&E High Tech Solution, Inc.
    Contact Name
    Lee JO
    Address
    8114 Telegraph road
    City
    Downey
    State
    CA
    ZIP
    90240
    Country
    US
    Email
    [email protected]
    Phone
    626 2883966

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP
    Applicator, Absorbent Tipped, Sterile KXG
    Clinical Sample Concentrator JJH
    Culture Media, Single Biochemical Test JSF
    General Purpose Reagent PPM
    Antigen, Id, Candida Albicans LHK
    Real Time Nucleic Acid Amplification System OOI
    Container, Specimen, Non-Sterile NNI
    Radioimmunoassay, Luteinizing Hormone CEP
    Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use JJC
    Container, Specimen, Sterile FMH
    Culture Media, Non-Selective And Non-Differential JSG
    Container, Specimen Mailer And Storage, Sterile KDT
    Immunoassay, Insulin-Like Growth Factor Binding Protein-1 OAM
    Kit, Identification, Neisseria Gonorrhoeae JSX
    Control, Fecal Occult Blood OSL
    Dna Probe, Trichomonas Vaginalis MJK
    Sperm, Antigen, Antiserum, Control DFQ
    Culture Media, Non-Propagating Transport JSM
    Station, Pipetting And Diluting, For Clinical Use JQW
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA

    Proprietary Names

    Bio-Self COVID-19 Antigen Home Test Disposable Sampling Swab Disposable sterile sampling swab Automated Nucleic Acid Extraction System Nucleic Acid Extraction Kit Disposable specimen collection kit Nucleic Acid Release Reagent Nucleic Acid Release Reagent (free extraction) Candida Albicans Antigen Rapid Test Kit (Immunochromatographic Assay) Candida Albicans/Trichomonas Vaginalis Antigen Rapid Test Kit (Immunochromatographic Assay) Automatic Nucleic Acid Detection System Disposable virus sampling Swab kits Luteinizing Hormone (LH) Rapid Test Kit (Immunochromatographic Assay) real-time fluorescent quantitative PCR instrument Fast real-time fluorescence PCR analyzer Disposable Specimen Container Disposable Virus Sampling Swab Kits Sample Preservation Swab Kits Insulin-like Growth Factor Binding Protein-1 Rapid Test Kit (Colloidal Gold Method) Neisseria Gonorrhoeae Antigen Rapid Test Kit (Immunochromatographic Assay) Fecal Occult Blood (FOB) Rapid Test Kit (Immunochromatographic Assay) Trichomonas Vaginalis Antigen Rapid Test Kit (Immunochromatographic Assay) Sperm SP10 Protein Rapid Test Kit (Immunochromatographic Assay) Sterile Disposable Virus Sampling Kits Automated Sample Transfer Processing System Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device