杭州微策生物技术有限公司

VivaChek Biotech (Hangzhou) Co., Ltd., located in Hangzhou China, is a professional manufacturer of medical diagnostic products like Immunofluorescence Analyzer and tests (CRP, hsCRP, PCT, D-Dimer etc), blood glucose meters and blood glucose test strips etc. We export to more than 80 countries including USA, Germany, Italy etc and most of the products are CE marked. Date of establishment: Aug 21, 2013 Subsidiary locations: USA, India, Hong Kong Number of employees: ~500 Patents granted: 60+ Investors: Shenzhen Gaotejia; Oriental International Holdings (China Top 500 company); Wuchan Zhongda Group (World Top 500 company) etc Recently we developed the VivaDiag SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) and VivaDiag SARS-CoV-2 Ag Rapid Test (both Colloidal Gold and FIA) which are in vitro diagnostic test for the qualitative determination of COVID-19’s antibodies or antigen and give results in 15 minutes. Certificates available: ISO 13485:2016, CE, FSC, Netherlands CIBG, UK MHRA, Australia TGA, Singapore HSA, Saudi MDMA, Russia, Ukraine, Colombia, Peru etc. We have submitted US FDA EUA and hope could get it soon. We also launched VivaGuardTM Infrared Thermometers HA-620, FT-100C and EF-100A, all of them are on the “white list” to export with CE and/or FDA 510k. VivaChek Biotech is also the # 1 Chinese manufacturer of blood glucose meters sold in Europe, in terms of units. The production facility is a 10,000 square meters state of the art facility. It utilizes fully automatic production lines with an annual output of up to500 million test strips. VivaChek Biotech has a stable and efficient quality management system to strictly follow all regulations established by the US FDA, the European Union CE, SFDA, ISO 13485, and EN ISO 15197: 2015.