北京美科美生物公司代理magqu

Analyzer
IMR Reagent
Beads and Separator


自2008年成立以来，MagQu利用其核心技术，即所谓的免疫磁还原（IMR），开发了数十种产品，如用于结直肠癌、阿尔茨海默病、唐氏综合征、早产、炎症性疾病、，石斑鱼病毒等。产品的研发和制造已通过ISO认证，包括9001和13485，以及GMP。此外，免疫分析分析仪已被卫生福利部台湾食品药品监督管理局（TFDA）批准为I类医疗器械。一些检测试剂盒将通过CE-IVD（2015）和TFDA（2016）认证。我们在中国、日本、韩国、马来西亚、土耳其、美国、英国和德国的生命科学市场上成功地将其投放市场。截至目前，自2008年以来，授权资本已从300万TWD筹集到150亿TWD。凭借辉煌的成就和令人印象深刻的进步，MagQu经常被台湾经济部、农业委员会和协会授予奖项。MagQu预计将于2016年获得卫生福利部对结直肠癌（II类）、阿尔茨海默病（III类）产品的营销授权。我们还计划在美国和欧洲开展临床试验，并在当地设立分支机构，扩大体外诊断试剂市场。在此期间，MagQu开发了石斑鱼病毒检测试剂盒，并已在市场上销售。MagQu已启动内部控制/审计系统，计划于2016年公开发行股票。
Since the start-up in 2008, MagQu has utilized her core technology, so-called ImmunoMagnetic Reduction (IMR), to develop dozens of products, such as in-vitro diagnostic (IVD) assay kits and analyzers for colorectal cancer, Alzheimer’s disease, Down’s syndrome, preterm birth, inflammatory disease, grouper viruses etc. The R&D and manufacture of products have been certified with both ISO including 9001 and 13485, and GMP. In addition, the immunoassay analyzers have been approved as Class-I Medical Device by Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare. Some of assay kits will be certificated with CE-IVD (2015) and TFDA (2016). We successfully made them on the shelf for life-science markets in China, Japan, Korea, Malaysia, Turkey, USA, UK, and Germany. Up to now, the authorized capital has been raised from 3 million to 1.5 hundred million TWD since 2008. With the bright achievements and impressive progresses, MagQu has been frequently awarded by Ministry of Economics, Council of Agriculture, and associations in Taiwan. MagQu is expected for colorectal cancer (Class II), Alzheimer’s disease (Class III) product marketing authorization of Health, Welfare Ministry in 2016. We also plan to start clinical trials of USA and Europe and place to set up branches, expanding in vitro diagnostic reagent market. During that time, MagQu has developed a grouper virus detection kit, and has been sold in the market. MagQu has initiated internal control/audit system, planning public offering of stock in 2016.