Snibe

Snibe (Shenzhen New Industries Biomedical Engineering Co., Ltd.) was founded in 1995. It is a national high-tech enterprise specializing in the research, development, production, sales, and service of in vitro diagnostic products, with a registered capital of 786.66 million RMB. Since its establishment, the company has been dedicated to research in the field of chemiluminescence immunoassays. After more than a decade of dedicated efforts, in September 2008, Snibe successfully completed the registration of China's first fully automated chemiluminescence analyzer and successfully launched it on the market. Through continuous technological innovation, the company introduced the intelligent "Modular Biochemical Immunoassay System" in 2016, further enriching its product line. In July 2017, Snibe passed the U.S. FDA 510(k) review, becoming the first chemiluminescence manufacturer in China to gain access to the U.S. FDA. In 2018, Snibe successfully released the ultra-high-speed fully automated chemiluminescence immunoassay system MAGLUMI® X8, ushering in a new era of ultra-high-speed chemiluminescence. In July 2019, Snibe's self-developed chemiluminescence product for hepatitis C successfully passed the EU CE List A certification, making it the first chemiluminescence manufacturer in China to have a hepatitis C reagent honored with EU CE certification. In December 2020, Snibe received China’s first IVDR CE certification in the chemiluminescence field, marking a new milestone on the path of being a global pioneer in the in vitro diagnostics field. Snibe is the first company in China to own the patent for "immunomagnetic microspheres" and use them as key separation materials in chemiluminescence systems. It is also the first company in China to own the patent for "artificially synthesized small-molecule organic compounds-ABEI" and use it as a luminescent label instead of traditional enzymes. Additionally, it is the first company in China to apply the above patented technologies, obtain domestic registration certificates, and achieve mass production of fully automated direct chemiluminescence immunoassay instruments and supporting reagents. The company’s R&D achievements have filled the gap in China’s in vitro diagnostics field, breaking the long-term monopoly and technical blockade by foreign manufacturers, and Snibe has become a leader in the field of quantitative chemiluminescence immunoassays in China.