Cov-2 Flu Plus Assay新冠加流感合併檢測套組

  • 搭配MDx3000 運行的定性檢測試劑盒
  • 通過緊急使用授權輸入
  • 供體外診斷使用
Cov-2 Flu Plus Assay新冠加流感合併檢測套組

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。

瑞磁CoV-2 Flu Plus Assay的特色與好處

通量

  • 8小時內提供188個檢體的檢測報告。

彈性

  • 掩蔽功能,僅提供醫師指示所要求的檢測項目,其他不顯示。

高效率

  • 一次採檢能夠區分新冠病毒, A型流感, B型流感, 與呼吸道融合病毒。 能夠與瑞磁通過FDA上市許可的其他檢測試劑同時上機平行檢測。

*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.