之江生物(688317.SH):全自動核酸提取及檢測分析系統獲得三類醫療器械註冊證
格隆匯9月20日丨之江生物(688317.SH)公佈,公司一項產品於近期獲得國家三類醫療器械註冊證,產品名稱為全自動核酸提取及檢測分析系統,適用範圍:全自動化樣本核酸提取純化及PCR檢測分析;預期用途:全自動核酸提取及檢測分析系統基於實時熒光PCR檢測原理,與配套的提取與檢測試劑共同使用,在臨牀上用於對來源於人體樣本中的靶核酸(DNA/RNA)進行定性、定量檢測,包括病原體、基因分型等項目。
公司上述產品整合了磁珠法核酸提取純化、PCR體系構建和qPCR擴增檢測系統三大核心功能,可實現多種樣本類型的全自動化核酸檢測流程。該產品全封閉負壓自動化操作,採用紫外+HEPA雙系統防止交叉污染,佔地面積小於0.4㎡,可高效解決核酸快速檢測需求,適用於各類實驗室,以及移動車載等空間環境相對有限的場所。
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