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)抗原檢測試劑盒在國內獲批上市,既豐富了公司產品的種類,又增強了公司綜合實力,還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內業務拓展具有積極的作用,還可以更好地為我國新冠疫情防控工作貢獻力量。
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