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Sentosa SX Sars-CoV-2 Reagent EUA 368/Bx

Sentosa SX 301068 Sars-CoV-2 Reagent

Laboratory / Molecular Testing / 1389755 | Vela Diagnostics USA, Inc - 301068
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Sentosa SX Sars-CoV-2 Reagent EUA 368/Bx
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Descripción del producto Resumen de las funciones del producto

Features & Benefits:

  • • This test has not been FDA cleared or approved
  • • This test has been authorized by FDA under an EUA for use by authorized laboratories
  • • This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens
  • • This test 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

Especificaciones Especificaciones y medidas de los productos

  • Additional Attributes
    PCR Test (EUA)
  • Brand
    Sentosa SX
  • CLIA Classification
    EUA
  • Item
    Reagent
  • Item Type
    Sars-CoV-2

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