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About Us
Hangzhou Clongene Biotech is a high-tech, leading manufacturer specializing in biological raw materials and in vitro diagnostic products. We have a solid reputation offering diversified services and superior flexibility to professional distributors and partnering affiliates in the global market.
Founded in 2004, Hangzhou Clongene Biotech is equipped with state-of-the-art ISO 13485:2016 accredited China GMP compliant R&D and manufacturing facilities covering 19,000 square meters in Hangzhou, China. Our products have obtained CE certificates, FSC certificates and US FDA 510(k) Clearances.
Main Product Lines
Raw materials
• Antibodies
• Antigens
• Enzymes
Immuno diagnosis
• Colloidal gold immunoassay
• Chemiluminescence immunoassay (CLIA)
• Fluorescence immunoassay (FIA)
Molecular diagnosis- PCR
History
2004
Clongene Biotech Co., Ltd. began. They established technology platforms of genetic engineering, monoclonal antibody and polyclonal antibody.
2006
Clongene Biotech Co., Ltd. began. They established technology platforms of genetic engineering, monoclonal antibody and polyclonal antibody.
2009
Obtained China Medical Device Manufacturer License.
2010
Obtained CE certification and ISO 13485 medical device quality management system certification.
2013
Approved as National High-tech Enterprise.
2015
Obtained ISO 9001 quality management system certification.
2016
Obtained US FDA 510(k) Clearances.
2017
Established technology platforms of RT-PCR, chemiluminescence immunoassay and fluorescence immunoassay. Approved as Provincial High-tech Enterprise R&D Center. Approved as Hangzhou Patent Pilot Enterprise.