Hangzhou Clongene Biotech Co., Ltd. is a high-tech enterprise specialized in biological raw materials and in vitro diagnostic products.
Founded in 2004, Clongene 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.
Our products main lines:
• Colloidal gold immunoassay
• Chemiluminescence immunoassay (CLIA)
• Fluorescence immunoassay (FIA)
• Molecular diagnosis- PCR
Clongene is a leading manufacturer in technology and in vitro diagnostic products, with a solid reputation and diversified services with superior flexibility to professional distributors and partnering affiliates to the global market.
COVID-19 Antigen Rapid Test
- CE certified
- Refundable according to TestV.
- Evaluated by Paul-Ehrlich-Institut PEI
- BfArM listed with the number AT 114/21 on the list of antigen tests for SARS-CoV-2
- PZN: 17292113 , PPN: 111729211309