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    About Clongene

    Founded in 2004, Hangzhou Clongene Biotech Co., Ltd. is a national high-tech enterprise specializing in providing Biological Raw Materials, diagnostic reagents, and CRO/CDMO services. 20 years of experience in the diagnostic industry, we have been committed to providing customers with high-quality products and professional technical services.

    Based on the platform of protein expression and antibody preparation, Clongene has developed antigens, antibodies and molecular diagnostic enzymes in the fields of infectious diseases, drugs of abuse, fertility, tumor markers, inflammation, food safety and veterinary diseases. After preparation, purification and verification, the biological raw materials can be applied to immunochromatography, ELISA, chemiluminescence and PCR. We can also provide customized services for biological raw materials according to customer needs.

    After 20 years of innovation and development, Clongene has developed colloidal gold/latex detection reagents, fluorescent immunoassay detection reagents, chemiluminescence detection reagents and PCR detection reagents. The main IVD reagents have obtained authoritative certifications including NMPA of China, FDA of US and CE of EU. The products were sold well in more than 100 countries and regions around the world.

    Clongene is committed to bringing more value to companies and units around the world with a wealth of products and professional services, and to bring more opportunities for distributors and partners.

    Product Platform

    Based on the above-mentioned technology platforms, the products of Clongene Biotech mainly cover the fields of infectious diseases, drugs of abuse, fertility, inflammation, serum proteins, cardiac markers, tumor markers and animal disease.

                          Biological Raw Materials                                IVD Products




                                        Colloidal gold immunoassay

                                        Fluorescent immunoassay

                                        Molecular diagnosis

                                        Chemiluminescence immunoassay

    Strengths and Mission
    Clongene features

    Clongene Biotech is a one-stop solution enterprise integrating biological raw materials, detection reagents and instruments.

    • High quality biological raw materials
    • Multi and stable detection reagents
    • Professional technical services

    Our mission and vision

    Clongene Biotech will continue to bring more value to companies and units around the world, and bring more opportunities to distributors and partners with rich products and professional services.


    * MDSAP


    * Protein Expression Service 

    * Recombinant Antibody Expression Service      

    * Construction of CHO-K1 Stable Cell Line


    COVID-19 Antigen rapid tests were listed in the first batch of EU mutual recognition list


    SARS-CoV-2 detection reagents have obtained the CE certification of EU, TGA certification of Australia and AVISA certification of Brazil


    *ISO 45001

    *ISO 14001


    *PCR technology platform

    *Chemiluminescence technology platform

    *Immunofluorescence technology platform

    *Province-level R&D Center in Zhejiang


    Obtained US FDA 510(k) Clearances


     ISO 9001 


    Approved as National High-tech Enterprise


    *CE Certification

    *ISO 13485 

    *Registration certificate of NMPA


    Obtained China Medical Device Manufacturer License


    *Immunochromatography technology platform

    *ELISA technology platform


    *Company Establishment

    *Genetic engineering technology platform

    *Monoclonal antibody technology platform

    Company Strength and Honor
    R&D Achievements
    Company Glories
    System Certifications
  • The main IVD reagents have obtained authoritative certifications including NMPA of China, FDA 510(k) clearances of US, TGA of Australia, CE of EU  and some other certifications from different countries, which demonstrate the quality of our products are approved by related government institutions. 

    With independent innovation capabilities and rich technical experience, Clongene has obtained dozens of invention patents and utility model patents. 

  • Clongene has been awarded as the innovation company in the key areas with national support, the Chinese People's Liberation Army material procurement supplier, Province-level R&D Center in Zhejiang, Patent Pilot Enterprise in Hangzhou and so on. 

  • Clongene Biotech always takes product quality as the first priority. We have a 100,000-level GMP clean production area that meets GMP requirements to ensure product safety and quality.

    Clongene Biotech has passed various system certifications such as ISO 13485, MDSAP, ISO 9001, ISO 45001, and ISO 14001 after 20 years of development.

  • National High-tech Enterprise
    Zhejiang Export Premium Brand
    Certificate of Export Commodity Brand
    Zhejiang High-tech Enterprise Research and Development Center
    Hangzhou Pilot Enterprise of Patent
    Hangzhou High-tech Enterprise Research and Development Center