万泰生物(603392.SH):HIV抗体口腔黏膜渗出液自我检测试剂取得医疗器械注册证

智通财经
Dec 25, 2025

智通财经APP讯,万泰生物(603392.SH)发布公告,近日,公司自主研发的人类免疫缺陷病毒(HIV1+2型)抗体口腔黏膜渗出液检测试剂盒(胶体金法)取得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(体外诊断试剂)》。

该产品是国内首个获批的用于自测口腔黏膜渗出液中的人类免疫缺陷病毒(HIV1+2型)抗体的试剂盒,这是公司继人类免疫缺陷病毒1型尿液抗体检测试剂盒(胶体金法)和人类免疫缺陷病毒(HIV1+2型)抗体检测试剂盒(胶体金法)后又一款获批的可用于消费者自测的HIV检测试剂盒,升级版的尿液自测试剂人类免疫缺陷病毒1+2型抗体尿液检测试剂盒(胶体金法)同步获得批准。标志着公司在艾滋病自我检测领域的技术领先地位和创新能力再次得到国家权威认可。

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