華大基因(300676.SZ):三項新型冠狀病毒檢測產品延續註冊
格隆匯 1 月 14日丨華大基因(300676.SZ)公佈,公司全資子公司華大生物科技(武漢)有限公司(以下簡稱武漢生物科技)的三項新型冠狀病毒檢測產品於2020年1月26日通過了國家藥品監督管理局(以下簡稱國家藥監局)的應急審批程序,獲得了國家藥監局頒發的醫療器械註冊證。具體內容詳見公司於2020年2月3日披露的《關於全資子公司取得醫療器械註冊證的公吿》(公吿編號:2020-006)。
近日,公司已按照國家藥監局的相關要求,完成了上述三項產品的延續註冊,並取得了相應的醫療器械證書,註冊證具體信息如下:


新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)是一款基於RT-PCR技術的快速檢測試劑盒;新型冠狀病毒2019-nCoV核酸檢測試劑盒(聯合探針錨定聚合測序法)則是基於宏基因組測序的檢測試劑盒。結合RT-PCR技術和宏基因組測序兩個檢測方法,可更快、更全面覆蓋2019-nCoV病毒檢測,並監測新型冠狀病毒在傳播過程中可能會發生的變異。
上述檢測產品的延續註冊,有利於維持新型冠狀病毒核酸檢測試劑供給能力,實現對新型冠狀病毒肺炎疑似病例、聚集性病例、其他需要進行新型冠狀病毒感染診斷或鑑別診斷者進行更快、更全面的檢測,全力協助疫情防控機構開展新型冠狀病毒感染的檢測工作,服務疫情防控需要。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.