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Solana Lyophilized Assay Kit CLIA Certified 48/Kt

Solana M312 Lyophilized Assay Kit

Laboratory / Molecular Testing / 1419768 | Quidel-Solana Product Line - M312
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  9. Solana Lyophilized Assay Kit CLIA Certified 48/Kt
Solana Lyophilized Assay Kit CLIA Certified 48/Kt
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Descripción del producto Resumen de las funciones del producto

  • • 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 of nucleic acid from SARS-CoV-2, 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Especificaciones Especificaciones y medidas de los productos

  • Brand
    Solana
  • CLIA Classification
    CLIA Certified
  • Item
    Assay Kit
  • Item Type
    Lyophilized

Description du catalogue Tal como se ve en nuestro catálogo impreso

This isothermal Reverse Transcriptase-Helicase-Dependent Amplification (RT-HDA) assay is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider. Molecular identification of SARS-CoV-2 occurs by the use of targeting highly conserved regions of the SARS-CoV-2 virus nonstructural Polyprotein (pp1ab). The assay consists of 2 major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using isothermal Reverse Transcriptase-Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which are performed in the Solana instrument. Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s 5 USB ports.

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