圣湘生物(688289.SH)取得一项医疗器械注册证

智通财经
27 Jan

智通财经APP讯,圣湘生物(688289.SH)发布公告,公司的产品基因测序仪SansureSeq1000于近日收到由国家药品监督管理局颁发的《医疗器械注册证》。

该产品采用可逆末端终止测序法,用于对来源于人体样本中的脱氧核糖核酸(DNA)进行测序,以检测基因变化,这些基因序列可用于辅助诊断疾病或疾病易感性。该仪器在临床上仅限于与国家药品监督管理部门批准的体外诊断试剂以及软件配合使用,且不用于人类全基因组的测序或从头测序。

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