两家公司4款新冠试剂产品获NMPA证（附出口资质清单）

admin

                    

                    

                    
                    
                    <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==&amp;mid=2651123504&amp;idx=2&amp;sn=1e48bdefd6b788bbb2bba803a1c7c262&amp;chksm=8481a07cb3f6296a816508a8b19c375210e5409f5baf1c5025f162d3d12185966532546369ae&amp;token=1710431095&amp;lang=zh_CN&amp;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==&amp;mid=2651008373&amp;idx=1&amp;sn=a77a3e7e6e29d6cd236488d2c42c66c3&amp;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 data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br  /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_14.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652974123&amp;idx=1&amp;sn=2d548f302bdbe4986b2f4e9c38411922&amp;chksm=843f4ebcb348c7aa159a894ebc80ab6a7c51f40beca14739db7b963328f73c592cea9fd44e62&amp;scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"><span>1700 家「协和医院」仅 3 家正牌，「协和」是怎样建成的？</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652974123&amp;idx=2&amp;sn=9ade9bd23b35c0e86ecf4414027419c2&amp;chksm=843f4ebcb348c7aadec0a472914029928e4a4be260298da08e622496fa58bba244b296192c6f&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>新加坡研发出中和抗体检测盒，或可找出无症状新冠患者</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652974121&amp;idx=1&amp;sn=a5154c35a510a9e141c9ebe727c3bbb8&amp;chksm=843f4ebeb348c7a823304bfdaaebd849caba39997da603561b1e6a85e776944c5e57658690e8&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>打脸特朗普！日本2019年初即检测出新冠抗体！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652974121&amp;idx=2&amp;sn=5a10a0e3032d0ab4909ffc9e90f52df2&amp;chksm=843f4ebeb348c7a89a247a5be1fe09d3894a3c27a5a65eb155912214d95d1cb4e1089d14c760&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>澳洲政府花费990万澳元从美国购买的测试盒不合格！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652974043&amp;idx=1&amp;sn=46f8f9601baea94443dbd5212fe46cc3&amp;chksm=843f494cb348c05a93625119e016e0fe5b770d721b2443be6e9b97be269516c805412574f678&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>受疫情影响，47亿美元收购案或生变！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652974043&amp;idx=2&amp;sn=ae1193e41486d1daa06ff9e81248c9f4&amp;chksm=843f494cb348c05aeec02fb863d0072c8e7807070c0492c2b14334d4f94d31239f6c97ce9c6f&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>国产 vs 进口9大品牌血糖仪测评，谁更胜一筹？</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973997&amp;idx=1&amp;sn=d09723562aafa0c648456a4813cc8568&amp;chksm=843f493ab348c02c8cb25e34cb763cf8a8d36d89b30276f0abcf5f2e18459579842a46aad0d4&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>首发！我国临床专家主导“1.5T磁共振厂家维修共识”发布</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973997&amp;idx=2&amp;sn=3ff31ab9a4fb404dda8181e48edd069f&amp;chksm=843f493ab348c02c8dabc26307a68d4d90624075275d510afa85e3d5038fc0c2742a21a0292a&amp;scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"><span>内窥镜三巨头奥林巴斯、富士胶片、宾得大比拼！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973997&amp;idx=3&amp;sn=4497c4879709ea0a72754f4e12f18dfa&amp;chksm=843f493ab348c02c539aaa296a1f06491ed9a127df8a22744982cab11a0cc4ed0016e54acacc&amp;scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"><span>比亚迪事件后续：我们不是受害者，加州追加1亿订单！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973945&amp;idx=1&amp;sn=7dfa831edbf51ee3b327d97752dcb867&amp;chksm=843f49eeb348c0f82a0253c157213a22081c22f68b841b1f38fa4f870329be45379e8f3ce628&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>战疫拐点后中国将迎来这三大医疗设计趋势</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973945&amp;idx=2&amp;sn=a63f11065fa033cd781cd72b923705e2&amp;chksm=843f49eeb348c0f845ac67f3ee6cc72f30911db1907543ae3591e0199a8cef9929535fadc254&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>谁是国内械企盈利之王？</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973945&amp;idx=3&amp;sn=011485a34b9238d5f95cf17c384bec6c&amp;chksm=843f49eeb348c0f84e8df75a906bb1ae00c9b754b2e90cf75a2936a4f417c99d6380d89cc4a9&amp;scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"><span>掌上X线机新鲜上线！移动影像科时代来了？</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973945&amp;idx=4&amp;sn=c3ef68f0e2d54a26b1804c1cb9ad96cc&amp;chksm=843f49eeb348c0f82bc9788815ac97c12f790070bec16aae5a9d2d5ec424648ea0d1c6eb7849&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>2019年中国大陆地区放疗人员和设备基本情况</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973897&amp;idx=1&amp;sn=a808d69f2dfb7181f1d5e055913acde8&amp;chksm=843f49deb348c0c8ac88c1bd83062d3f07729ed1ec92caa80573406daa22f12f6c16009520f1&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>GE新品发布——百万级像素重新定义64排CT！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><span><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&amp;mid=2652973897&amp;idx=2&amp;sn=3e28ec6741aeaf23b845417115c22bef&amp;chksm=843f49deb348c0c863760ec31b3755a5a44f94594857cadf0717ad10599e48984a82dc180790&amp;scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">6类防疫物资，全国暂停出口！</a></span></section></section></section></section></section></section></section></section></section><p><br  /></p><p><p><img src="image/20201014/aad9f56b0707b5374bbac6273a663447_15.jpg" /></p></p>