華大基因(300676.SZ)：控股子公司十五項產品取得醫療器械註冊證
格隆匯2月18日丨華大基因(300676.SZ)公佈，公司控股子公司北京華大吉比愛生物技術有限公司(華大吉比愛)的十五項基於磁微粒化學發光免疫分析法檢測試劑盒於近日取得了北京市藥品監督管理局頒發的醫療器械註冊證。
產品名稱分別為降鈣素原測定試劑盒(磁微粒化學發光免疫分析法)、白介素-6測定試劑盒(磁微粒化學發光免疫分析法)、氨基末端腦利鈉肽前體測定試劑盒(磁微粒化學發光免疫分析法)、孕酮測定試劑盒(磁微粒化學發光免疫分析法)、血清澱粉樣蛋白A測定試劑盒(磁微粒化學發光免疫分析法)、心臟型脂肪酸結合蛋白測定試劑盒(磁微粒化學發光免疫分析法)、促黃體生成素測定試劑盒(磁微粒化學發光免疫分析法)、肌鈣蛋白I測定試劑盒(磁微粒化學發光免疫分析法)、胃蛋白酶原II測定試劑盒(磁微粒化學發光免疫分析法)、β-人絨毛膜促性腺激素測定試劑盒(磁微粒化學發光免疫分析法)、胃蛋白酶原I測定試劑盒(磁微粒化學發光免疫分析法)、肌紅蛋白測定試劑盒(磁微粒化學發光免疫分析法)、肌酸激酶同工酶測定試劑盒(磁微粒化學發光免疫分析法)、促卵泡生成素測定試劑盒(磁微粒化學發光免疫分析法)、超敏C反應蛋白測定試劑盒(磁微粒化學發光免疫分析法)。
上述第1、2、5項檢測試劑盒屬於感染防控相關的檢測產品，第3、6、8、12、13、15項檢測試劑盒屬於心血管相關的檢測產品，第4、7、10、14項檢測試劑盒屬於生育健康相關的檢測產品，第9、11項檢測試劑盒屬於慢病管理相關的檢測產品。
磁微粒化學發光免疫分析技術是將磁性分離技術、化學發光技術、免疫分析技術三者結合的分析方法，具有靈敏度高、光信號持續時間長、檢測結果穩定、磁性分離技術的快速易自動化、操作簡便等優點，是目前免疫診斷領域國際先進的主流技術之一。華大吉比愛此次獲證的十五項檢測試劑盒需聯合公司全自動化學發光免疫分析儀使用，實現快速檢驗，更好地滿足臨牀即時檢測(POCT)的需求。
上述十五項產品取得醫療器械註冊證，標誌着該等產品具備了獲批上市的資質，豐富了公司臨牀檢測產品的資質結構，增強了產品競爭力。
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.
