Descripción del producto Resumen de las funciones del producto

• • This Test Has Not Been FDA Cleared Or Approved;


• • In The United States (US), Testing With Cobas® SARS-CoV-2 & Influenza A/B Is Authorized For Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. §263a, To Perform Moderate Or High Complexity Tests For Use On Cobas® Liat System. Cobas® SARSCoV-2 & Influenza A/B Is Also Authorized For Use At The Point Of Care (POC), I.e., In Patient Care Settings Operating Under A CLIA Certificate Of Waiver, Certificate Of Compliance, Or Certificate Of Accreditation For Use On Cobas® Liat System.


• • This Test Has Been Authorized Only For The Simultaneous Qualitative Detection And Differentiation Of Nucleic Acid From SARS-CoV-2, Influenza A Virus And Influenza B Virus And Not For Any Other Viruses Or Pathogens.


• • This Test Is Only Authorized In The United States For The Duration Of The Declaration That Circumstances Exist Justifying The Authorization Of Emergency Use Of In Vitro Diagnostic Tests For Detection And/or Diagnosis Of COVID-19 Under Section 564(b)(1) Of The Act, 21 U.S.C. § 360bbb-3(b)(1), Unless The Authorization Is Terminated Or Revoked Sooner.

Especificaciones Especificaciones y medidas de los productos

• Brand
  Cobas
• CLIA Classification
  CLIA Waived
• For
  Cobas Liat
• Item
  Assay Kit
• Item Type
  Sars-CoV-2-Flu A/B
• Quantity
  20/Box

Productos suplentes (1) Este producto no se encuentra disponible. Vea los productos suplentes a continuación:

Description du catalogue Tal como se ve en nuestro catálogo impreso

The cobas^® SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas^® Liat^® System is a multiplex, real-time polymerase chain reaction (PCR) test that detects and differentiates SARS-CoV-2, influenza A and influenza B in 20 minutes from a single nasal sample and in just one test.