两家公司4款新冠试剂产品获NMPA证（附出口资质清单）

admin · 发表于 2020-10-14 12:20:07

                  <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><br  /></section><section><span>来源：中国体外诊断网 CAIVD</span></section><section><br  /></section><section data-color="rgb(55, 74, 174)" data-style-id="24014" data-support="96编辑器"><section><section><section data-support="96编辑器" data-style-id="26341"><section><section><section><p><span>5月15日，郑州安图生物工程股份有限公司两款产品新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（磁微粒化学发光法）、新型冠状病毒（2019-nCoV）IgG抗体检测试剂盒（磁微粒化学发光法）获得国家药监局注册证。5月18日，迈克生物科技股份有限公司两款产品新型冠状病毒（2019-nCoV）IgG抗体检测试剂盒（直接化学发光法）、新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（直接化学发光法）获得国家药监局注册证</span></p><p><br  /></p></section></section></section></section><p><p><img src="image/20201014/0824aa9b1e0612a168765613ab891766_2.png" /></p></p><p><p><img src="image/20201014/86cd55493093961ac657b18d175acf16_3.png" /></p></p><p><p><img src="image/20201014/f79c55ab21ab2e2b62b4b1a81bbdfc70_4.png" /></p></p><p><p><img src="image/20201014/5e2e81e2c61aa0c5fa2190c507277ade_5.png" /></p></p><p><p><img src="image/20201014/c070d5785f9f752403d86c7466f2e694_6.png" /></p></p><section data-support="96编辑器" data-style-id="26341"><section><section><section><p><br  /></p><p><span>自新冠疫情发生以来，中国IVD企业反应迅速，夜以继日、迎难而上、科研攻关、捐款捐物为这场全民抗“疫”提供充足的医疗保障，截至目前，国内30家企业新冠产品获得国家药监局医疗器械注册证，产品涉及检测试剂盒、仪器和软件。</span></p><p><br  /></p></section></section></section></section><p><p><img src="image/20201014/8b222e06c0f47fc77aa3d06925ace71e_7.png" /></p></p><p><span></span></p><section data-support="96编辑器" data-style-id="26341"><section><section><section><p><span></span><span>自国家相关部门发布</span><a target="_blank" href="https://mp.weixin.qq.com/s?__biz=MzA3NTM0ODUxNQ==&mid=2651123504&idx=2&sn=1e48bdefd6b788bbb2bba803a1c7c262&chksm=8481a07cb3f6296a816508a8b19c375210e5409f5baf1c5025f162d3d12185966532546369ae&token=1710431095&lang=zh_CN&scene=21#wechat_redirect" textvalue="5号" tab="innerlink" data-linktype="2"><strong>5号</strong></a><span>、</span><a target="_blank" href="https://mp.weixin.qq.com/s?__biz=MzA3NjA5NDM0Mw==&mid=2651008373&idx=1&sn=a77a3e7e6e29d6cd236488d2c42c66c3&scene=21#wechat_redirect" textvalue="12号" tab="innerlink" data-linktype="2"><strong>12号</strong></a><span>公告以来，根据医保商会更新名单，已有178家企业获得新冠检测产品出口资质，澳大利亚TGA 3 家，美国EUA 7 家，欧盟CE 176 家，并且多家企业获得不同出口国“双证”，中国IVD企业出海大大的为世界疫情作出贡献。</span></p></section></section></section></section><p><p><img src="image/20201014/11c81150d4ea81a2946dcc6745ad556a_8.png" /></p></p><p><p><img src="image/20201014/67515003d2f03a237f6992b7f462b299_9.png" /></p></p><p><p><img src="image/20201014/fc424073536c99cbeb0d03d619842ade_10.png" /></p></p><p><p><img src="image/20201014/d1bc7d1c2aa0f1f7c8bd9f7899570e0b_11.png" /></p></p><p><p><img src="image/20201014/fbef9dd3222e0d0219371400529df046_12.png" /></p></p><p><p><img src="image/20201014/933706be9019cfb2d9296f3e7a6d2a91_13.png" /></p></p><p><br  /></p></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section 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