智通财经APP讯,万泰生物(603392.SH)发布公告,近日,公司收到世界卫生组织(以下简称“WHO”)出具的体外诊断预认证(PQ)确认函,公司的HIV尿液自检试剂-人类免疫缺陷病毒 1 型尿液抗体检测试剂盒(胶体金法)(英文名称:HIV SELF TEST BY URINE – Human Immunodeficiency Virus (HIV) Type-I Urine Antibody Diagnostic Kit (Colloidal Gold))已通过WHO 的预认证,被WHO列入体外诊断产品预认证清单。
这是继公司的人类免疫缺陷病毒抗体诊断试剂盒(酶联免疫法)及人类免疫缺陷病毒(HIV 1+2 型)抗体检测试剂盒(胶体金法)通过 WHO PQ 认证后,第三款通过 WHO PQ 认证的 HIV 检测产品,同时是全球首款获得 WHO PQ 的 HIV 抗体尿液自检试剂盒。标志着公司的产品性能及质量管理体系再次获得国际认可。
作为全球首款 HIV 抗体尿液自检试剂盒,获得 WHO PQ 认证意味着公司的HIV 抗体尿液自检试剂盒获得了国际权威认可,可直接参与联合国及全球多边机构的集中采购项目,覆盖更多中低收入国家和地区,将对公司开拓国际市场带来积极影响,有利于进一步提升公司产品的国际竞争力。
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