BioDetect Brand Rapid SARS-CoV-2 Antigen Test Card (Colloidal gold method) were approved for China local Market!

        On August 10, 2023, BioDetect Rapid SARS-CoV-2 Antigen Test Card (Colloidal gold method) was registered and approved by the State Food and Drug Administration, registration number: Guoxiezhuzhun 20233401116. The product is suitable for in vitro qualitative detection of novel coronavirus (2019-nCov) N antigen in nasal swab samples, and has good detection effect on both the original strain and the variant strains of concern (VOC) including Omicron.

Product advantages: Simple and Convenient, Instant detection, 15min results, easy to use, safe and reliable.

         In combination with the technical strength of Xiamen University, the R&D team of BioDect Company has developed products such as Rapid Sars-CoV-2 Antigen Test Card, nucleic acid extraction and purification reagent and sample release agent. Relying on the stability of the products, it has won a good market reputation. Among them, the disposable virus sampling tube obtained CE certification and passed the FDA registration; The rapid Sars-CoV-2 antigen test has obtained CE1434, Thailand FDA and Malaysia MDA certification, and has obtained registration and entry permits in Germany BfArm, France ANSM, Italy AIFA, Spain AEMPS and Austria BASG. In July 2022, Boditai's Rapid Sars-CoV-2 Antigen Test Card was included in the EU Common list by the European Commission for Public Safety and listed as A Class A product.At the same time, relying on the technical strength of Xiamen University, we focus on the innovative "gene editing technology-mediated microfluidic chip" for rapid genetic diagnosis.

        Biodetect (Xiamen) Biotechnology Co., Ltd. was founded by the overseas doctor team on July 04, 2017, specializing in the development and production of in vitro diagnostic reagents, and was selected as the leading entrepreneurial talent project of Xiamen "Double Hundred Plan" in 2017. The company is headquartered in Xiamen Biopharmaceutic Industrial Park, a national incubation base. The core technical team brings together a number of postdocs, doctors and overseas returnees. Academicians of the Chinese Academy of Sciences and experts of the "Thousand Talents Plan" serve as technical advisers.