智通财经APP讯,华大智造(688114.SH)发布公告,公司全资子公司青岛华大智造科技有限责任公司的基因测序仪产品于近日取得了中华人民共和国医疗器械注册证。
该产品采用联合探针锚定聚合测序技术,在临床上用于对来源于人体样本的人脱氧核糖核酸(DNA)进行测序,以检测基因序列,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,不用于人类全基因组的测序或从头测序。
上述医疗器械注册证书的取得,有利于公司及子公司基因测序仪业务工作的全面开展,将进一步提高公司及子公司的综合竞争力,对公司及子公司的可持续性发展产生积极影响和促进作用。
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