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.
Clongene Biotech is a one-stop solution enterprise integrating biological raw materials, detection reagents and instruments.
• High quality biological raw materials
• Stable detection reagents
• Professional technical services
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.
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
*Approved as National High-tech Enterprise
*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
Obtained China Medical Device Manufacturer License
*Immunochromatography technology platform
*ELISA technology platform
*Company Establishment
*Genetic engineering technology platform
*Monoclonal antibody technology platform
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.
