基蛋生物(603387.SH):完成醫療器械註冊證變更登記及取得醫療器械註冊證
格隆匯 9 月 8日丨基蛋生物(603387.SH)公佈,公司於近日收到由國家藥品監督管理局頒發的1項《醫療器械註冊變更文件(體外診斷試劑)》具體情況如下:

公司於近日收到了由江蘇省藥品監督管理局頒發的2項《醫療器械註冊證(體外診斷試劑)》,具體情況如下:

截至2020年6月30日,肝腎功能四聯檢測試劑盒(乾式化學分析法)累計已發生的研發投入約為90.53萬元;同型半胱氨酸/肌酸激酶同工酶/心肌肌鈣蛋白I/肌紅蛋白四合一檢測試劑盒(乾式化學分析法+乾式免疫熒光法)累計已發生的研發投入約為85.76萬元。
根據國家藥品監督管理局官網數據查詢信息:截止公告日國內外同行業多個廠家已取得同類產品的醫療器械註冊證書,丙氨酸氨基轉移酶檢測試劑盒國內註冊證237個,進口註冊證19個;天門冬氨酸氨基轉移酶檢測試劑盒國內註冊證238個,進口註冊證10個;肌酐檢測試劑盒國內註冊證293個,進口註冊證35個;尿素檢測試劑盒國內註冊證233個,進口註冊證23個;同時檢測丙氨酸氨基轉移酶、天門冬氨酸氨基轉移酶、肌酐、尿素檢測試劑盒國內註冊證0個,進口註冊證0個。同型半胱氨酸檢測試劑盒國內註冊證219個,進口註冊證12個;肌酸激酶同工酶檢測試劑盒國內註冊證389個,進口註冊證27個;心肌肌鈣蛋白I檢測試劑盒國內註冊證280個,進口註冊證6個;肌紅蛋白檢測試劑盒國內註冊證388個,進口註冊證39個;同時檢測同型半胱氨酸、肌酸激酶同工酶、心肌肌鈣蛋白I、肌紅蛋白檢測試劑盒國內註冊證0個,進口註冊證0個。
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.