BioDetect (Xiamen) Biotechnology Co., LTD.     

BioDetect (Xiamen) Biotechnology Co., LTD.. is located in the Haicang Biomedical Industrial Park in Xiamen. It was founded by a team of PhDs returning from overseas and specializes in the R&D, production, sales, and service of In Vitro Diagnostics (IVD) reagents. The company is an innovative national high-tech enterprise integrating these functions.

The BioDetect R&D team, in collaboration with the technical strength of Xiamen University, has developed products such as the Influenza A/B Virus Antigen Test Kit, COVID-19 Antigen Test Kit, Nucleic Acid Extraction Reagent, Nucleic Acid Extraction and Purification Reagent, and Sample Release Agent. Thanks to the stability of these products, Boditech has earned a good market reputation. Notably, the COVID-19 Antigen Rapid Test Kit has received the European Union CE1434 certification, approval for the China Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal Gold Method) in 2023, and certifications from Thailand's FDA and Malaysia's MDA. Additionally, it has achieved registration and access in countries like Germany BfArm, France ANSM, Italy's Ministry of Health, Spain AEMPS, and Austria BASG.

BioDetect has successively received numerous honors and awards, including National Support for Overseas-educated Entrepreneurs, National High-tech Enterprise, Fujian Province Science and Technology Small Giant, Fujian Province "Hundred Talents Program," Fujian Province "Specialized, Fined, Peculiar, and Innovative" SMEs, Xiamen City "Double Hundred Talents" Leading Entrepreneurial Talent, Xiamen Major Science and Technology Project, Xiamen Epidemic Prevention and Control Emergency Research, "Future Victory," "Egret Star," and the National Postdoctoral Innovation and Entrepreneurship Competition Silver Award.

Currently, BioDetect is a reserve enterprise of the Xiamen Municipal Government and a supplier to major domestic tertiary hospitals. In June 2020, the company's quality management system passed ISO13485 certification. In July 2022, the company passed the British BSCI factory inspection. In September 2023, it obtained the Medical Device Production License.