透景生命(300642.SZ):人类免疫缺陷病毒抗原抗体联合检测试剂盒(化学发光免疫分析法)医疗器械注册获受理

智通财经
May 25

智通财经APP讯,透景生命(300642.SZ)发布公告,公司申报的医疗器械注册申请于近日获得了国家药品监督管理局的受理,该产品为:“人类免疫缺陷病毒抗原抗体联合检测试剂盒(化学发光免疫分析法)”。

上述受理产品可检测出HIV-1 P24抗原以及HIV-1型、HIV-2型以及HIV-1 型O组抗体,能更早的检测到HIV病毒感染状况,用于临床HIV-1型病毒和HIV-2 型病毒感染的辅助诊断。检测结果不具体区分HIV-1P24抗原、HIV-1抗体、HIV-2 抗体或HIV-1型O组抗体反应性。

本次获得受理的产品为公司基于化学发光技术平台开发的感染检测领域产品,有利于丰富公司的产品矩阵。丰富、齐全的产品线有助于公司全方位的满足市场需求,进一步提高公司的市场竞争力。

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