康為世紀(688426.SH)：艱難梭菌tpi和毒素A、毒素B基因檢測試劑盒(熒光PCR法)獲三類醫療器械註冊證

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3小時前

智通財經APP訊，康為世紀(688426.SH)發布公告，近日，公司全資子公司江蘇健為診斷科技有限公司(簡稱「健為診斷」)自主研發的艱難梭菌tpi和毒素A、毒素B基因檢測試劑盒(熒光PCR法)獲得國家藥品監督管理局頒發的Ⅲ類《醫療器械註冊證(體外診斷試劑)》。

健為診斷自主研發的消化道病原體檢測產品「艱難梭菌tpi和毒素A、毒素B基因檢測試劑盒(熒光PCR法)」，採用熒光PCR技術，以艱難梭菌(Clostridioidesdifficile)基因組中tpi、tcdA和tcdB基因的特異性序列為靶區域，分別設計特異性引物與探針，對其進行多重PCR擴增及檢測。該產品通過對糞便樣本中tpi、tcdA及tcdB基因的同步檢測，輔助臨床診斷艱難梭菌感染。

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