艾德生物(300685.SZ):“人类微卫星不稳定性(MSI)检测试剂盒(荧光PCR熔解曲线法)”获得医疗器械注册证

智通财经
May 20

智通财经APP讯,艾德生物(300685.SZ)发布公告,公司于近日获得由国家药品监督管理局颁发的《中华人民共和国医疗器械注册证》,该产品为:“人类微卫星不稳定性(MSI)检测试剂盒(荧光PCR熔解曲线法)”。

该产品用于体外定性检测结直肠癌患者肿瘤组织FFPE样本中的微卫星位点(ACVR2A、PRR5-ARHGAP8、EIF4E3、IFT140、RBM14-RBM4、UBAC2)。根据发生序列长度变化的微卫星位点数量,将结直肠癌分为微卫星高度不稳定型(MSI-H)与非微卫星高度不稳定型(MSS/MSI-L)两种微卫星状态。

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