Molecular Reagent BD MAX™ SARS-CoV-2, Influenza A / B For BD MAX System 24 Tests

Features

• BD SARS-CoV-2/Flu for BD MAX™ System are for Emergency Use Authorization only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform moderate and high complexity tests
• BD SARS-CoV-2/Flu for BD MAX™ System is an automated multiplexed real-time RT-PCR test intended for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A and/or influenza B in nasopharyngeal and anterior nasal swabs collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider
• Positive results do not rule out bacterial infection or co-infection with other viruses
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information
• BD SARS-CoV-2/Flu for BD MAX™ System is intended for use by qualified clinical laboratory personnel specifically instructed and trained on the use of the BD MAX™ System and in vitro diagnostic procedures
• Kit contains: (24) Tubes BD SARS-CoV-2/Flu for BD MAX™ System Master Mix (D9), (24) BD Respiratory for BD MAX™ System Extraction Tubes (D4), (24) BD Respiratory for BD MAX™ System Unitized Reagent Strips, (24) BD Molecular Respiratory Sample Buffer Tubes and 25 Septum Caps

More Information

• BD MAX SARS-CoV-2 and Flu Reagent Kit FDA EUA Letter
• BD MAX SARS-CoV-2 and Flu Reagent Kit IFU
• BD MAX SARS-CoV-2 and Flu Reagent Kit Patients Fact Sheet
• BD MAX SARS-CoV-2 and Flu Reagent Kit Healthcare Providers Fact Sheet
• SDS