達安基因(002030.SZ):新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)取得醫療器械註冊證
格隆匯 9 月 23日丨達安基因(002030.SZ)公佈,近日,公司取得國家藥品監督管理局頒發的醫療器械註冊證一個,具體為:
1、醫療器械名稱:新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法),註冊證編號:國械注準20203400749。自批准之日起有效期至二零二一年九月二十日。
目前,公司已獲得“新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)”的醫療器械註冊證,該產品與公司於2020年2月2日公告中取得的“新型冠狀病毒(2019-nCoV)核酸檢測試劑盒(熒光PCR法)(註冊證編號:國械注準20203400063)”產品的主要區別在於:
(1)本試劑盒包含單管單人份的包裝規格,使用者無需進行反應體系配製,可直接加入樣本核酸後進行PCR反應,簡化了操作流程;
(2)反應體系中添加了UDG酶,可以起到防污染作用;
(3)反應體系使用經過改造的酶,可以縮短檢測時間;
(4)本試劑盒推薦配套使用的公司生產的核酸提取或純化試劑(備案號:粵穗械備20200293號),簡單操作即可在短時間內獲得咽拭子樣本中的核酸,縮短樣本檢測時間。
鑑於新型冠狀病毒疫情發展、產品的非唯一性以及同類產品競爭等不確定因素的影響,上述產品註冊證對公司業績的影響目前尚無法估計,請廣大投資者注意投資風險。
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