Hangzhou Clongene Biotech Co., Ltd. is a national high-tech enterprise based in Hangzhou, China. We are specializing in the R&D, production and sales of biological raw materials, IVD reagents and instruments. In addition, we can also provide CRO & CDMO services.
As a well-known supplier of biological raw materials in China, we provide products and services to major domestic IVD products manufactures and scientific research institutions. Our 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. We can also provide customers with high-quality technical services, including protein expression services, recombinant antibody expression services and CHO-K1 stable cell line construction services.
While continuously innovating the products, we always commit to product innovation and strict quality control. We pursue to provide our customers with high-quality products and excellent service through infinite trust and responsibility.
| Biological Raw Materials | IVD Products | CRO & CDMO Services |
Antibodies Antigens Enzymes. | Colloidal gold immunoassay Fluorescent immunoassay Molecular diagnosis Chemiluminescence immunoassay | Protein expression services Recombinant antibody expression services CHO-K1 stable cell line construction services |
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, cardiac markers and tumor markers.
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
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.
* 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
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.
