安必平(688393.SH):人乳頭瘤病毒核酸檢測試劑盒取得醫療器械註冊證
格隆匯7月9日丨安必平(688393.SH)公佈,近日收到由國家藥品監督管理局頒發的《醫療器械註冊證(體外診斷試劑)》,產品名稱:人乳頭瘤病毒核酸檢測試劑盒(實時熒光PCR法)。該產品用於體外定性檢測女性宮頸樣本(宮頸脱落細胞)中的18種中高危型人乳頭瘤病毒(HPV)DNA,並同時對其中的HPV16和HPV18型進行分型檢測。與公司現有HPV檢測產品形成互補,進一步拓寬宮頸癌檢測市場。公司積極響應國家消除宮頸癌的戰略目標,經過多年研發積累,現已成為國內少數擁有“細胞學檢查+HPV檢測+p16/Ki67雙染檢測”全鏈條篩查方案的企業,並開發出涵蓋“細胞學試劑+製片設備+掃描儀+AI判讀”的宮頸癌篩查智能化整體解決方案。該註冊證的取得有助於擴充公司在腫瘤篩查與診斷領域的戰略佈局,塑造獨特的競爭優勢。
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