On the morning of 3rd November, Yu Kaihai, Fujian Food and Drug Administration Bureau leading party group secretary and director, and Huang Weijun, Provincial Food and Drug Administration Bureau Medical Instrument Supervision Section director, and Wu Rui, Provincial Food and Drug Administration Bureau Inspection Office visited Xiamen Innodx, to inspect the product development and industrialization of the medical device registration certificate for the first Novel Coronavirus (2019-nCOV) antibody test kit in our province. The visiting group was accompanied by Mr. Yang Xueyong, Director of Xiamen Food and Drug Administration, and Mr. Zhang Shanmei, leader of Haicang District Government.
Professor Xia Ningshao, Dean of Xiamen University Public Health School, General Manager Sun Xudong of Xiamen Innodx, and General Manager Gao Yongzhong of Xiamen Innovax, General Manager Xu Feihai of Xiamen Umic were presented. Dr. Liu Wei Song of the R&D Department mainly introduced the Novel Coronavirus (2019-nCOV) total antibody diagnostic kit and related supporting equipment automatic Chemiluminescence Immunoassay analyzer (Caris 200), and evaluated the safety, efficiency and accuracy of the kit with clinical data.
Professor Xia Ningshao said, in addition to the Novel Coronavirus Total Antibody diagnostic kit, other relevant reagents had recently obtained CE certification in the European Union. The Novel Coronavirus IgM antibody diagnostic kit and the new generation of automatic Chemiluminescence Immunoassay analyzer (Wan 200+) have also entered the evaluation stage.The accelerated launch of these products will further promote the prevention and control of the epidemic at home and abroad.
Director Yu Kaihai said, our goal were same which was Public health first. As the first approved enterprise in Fujian province, we will strengthen the supervision of products from the aspects of production capacity, quality assurance and transportation control more strictly.Products that developed so quickly and practically applied in heavy epidemic areas brought far greater social benefits than the economic benefits."Build up the horse and walk well again" government and enterprise can not only joint together to supervise of approved products, but also actively track the approval of other related products.