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    About Clongene

    Hangzhou Clongene Biotech Co., Ltd. is a national high-tech enterprise specializing in the R&D, production and sales of biological raw materials, IVD reagents and instruments.

    Clongene is a well-known supplier of biological raw materials in China, providing products and services to major domestic IVD products manufactures and scientific research institutions.

    The IVD products developed by Clongene include 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 510(k) clearances of US, TGA of Australia, CE of EU  and some other certifications from different countries. The products have been sold well in more than 100 countries and regions around the world.

    Product Platform
    Clongene Biotech has established the biological raw materials preparation platform, colloidal gold/latex immunoassay technology platform, immunofluorescence technology platform, chemiluminescence technology platform, PCR detection technology platform, equipment R&D and production platform and technical service platform with independent innovation capabilities and rich technical experience.

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


    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.

    Milestone
    2022

    * Protein Expression Service 

    * Recombinant Antibody Expression Service      

    * Construction of CHO-K1 Stable Cell Line

    2021

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

    2020

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


    2019

    *ISO 45001

    *ISO 14001


    2017

    *PCR technology platform

    *Chemiluminescence technology platform

    *Immunofluorescence technology platform

    *Province-level R&D Center in Zhejiang

    2016

    Obtained US FDA 510(k) Clearances

    2015

     ISO 9001 

    2013

    Approved as National High-tech Enterprise

    2010

    *CE Certification

    *ISO 13485 

    *Registration certificate of NMPA


    2009

    Obtained China Medical Device Manufacturer License

    2006

    *Immunochromatography technology platform

    *ELISA technology platform


    2004

    *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, ISO 9001, ISO 45001, and ISO 14001 after 18 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
    ISO 13485
    ISO 9001
    ISO 14001
    ISO 45001