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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.

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