瑞磁新冠加流感七合一檢測套組是一套多目標核酸檢測的試劑盒,從鼻腔拭子樣本中定性檢測與區分包括SARS-CoV-2, Influenza A與分型, Influenza B, and Respiratory Syncytial Virus (RSV) 等各項病毒RNA。
它可以單獨運行或搭配通過衛福部核准的瑞磁呼吸道適應症多元檢測套組平行運作,更全面性的檢測造成呼吸道感染症狀的病原體。
*This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, Influenza A (with H1 pdm09, H1 seasonal, H3 subtypes), Influenza B and/or Respiratory Syncytial Virus (RSV), not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.