Research - Tianjin, Tianjin, China
NewScen Coast is based on independent innovation and relies on talent sharing at home and abroad, information interaction advantage, antibody preparation, and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession. HIV (1 + 2) antibody rapid test obtained national patent and the national second class of new drug certificate; HCV antibody rapid test is the first double antigen sandwich test HCV patented product; NewScen's quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of the colloidal gold test. Rapid immunoassay reader provides an open and common platform for qualitative and quantitative detection of the colloidal gold test. The company has received CFDA medical device certificates of 32 products, 49 independent intellectual property rights, FDA certificates of 3 products, and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa, and other international markets.Currently, the company integrated colloidal gold test, immunochromatographic interpret scope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate, and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.
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