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熱景生物(688068.SH):新型冠狀病毒抗原檢測試劑盒在國內獲批上市
格隆匯 03-14 15:31

格隆匯3月14日丨熱景生物(688068.SH)公佈,公司自主研發生產的新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(膠體金法)於近日收到國家藥品監督管理局頒發的《醫療器械註冊證》(註冊證編號:國械注準20223400348)。

公司上述新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(膠體金法)是對鼻拭子樣本中新型冠狀病毒抗原的檢測,按照《新冠病毒抗原檢測應用方案(試行)》的相關要求,可用於以下三類人員的檢測:(一)到基層醫療衞生機構就診,伴有呼吸道、發熱等症狀且出現症狀5天以內的人員;(二)隔離觀察人員,包括居家隔離觀察、密接和次密接、入境隔離觀察、封控區和管控區的人員;(三)有抗原自我檢測需求的社區居民。以上人員在使用新型冠狀病毒抗原檢測試劑時應遵循《新冠病毒抗原檢測應用方案(試行)》等國家的相關管理要求。

公司新型冠狀病毒(2019-nCoV)抗原檢測試劑國內獲批上市,豐富了公司產品的種類增強了公司綜合實力有助於提升公司在相關領域的競爭力不僅對公司銷售及國業務拓展具有積極的作用還可以更好地我國新冠疫情防控工作貢獻力量

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