康为世纪(688426.SH):九项呼吸道病原体核酸检测试剂盒(荧光PCR法)获医疗器械注册证

智通财经
Mar 04

智通财经APP讯,康为世纪(688426.SH)公告,公司全资子公司江苏健为诊断科技有限公司(简称“健为诊断”)自主研发的九项呼吸道病原体核酸检测试剂盒(荧光PCR法)收到国家药品监督管理局颁发的III类《医疗器械注册证(体外诊断试剂)》。

据公告所示,健为诊断此次自主研发的呼吸道病原体检测产品“九项呼吸道病原体核酸检测试剂盒(荧光PCR法)”是一款基于荧光定量PCR方法,采用了先进的冻干技术,在体外定性检测人咽拭子样本中的甲型流感病毒(FluA)、乙型流感病毒(FluB)、呼吸道合胞病毒(RSV)、人鼻病毒(HRV)、肺炎支原体(MP)、腺病毒(ADV)、副流感病毒Ⅰ型(PIVⅠ)、副流感病毒Ⅱ型(PIVⅡ)及副流感病毒Ⅲ型(PIVⅢ)核酸的产品。

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