Molecular Reagent BD MAX™ SARS-CoV-2 For BD MAX System 24 Tests

Features

• BD SARS-CoV-2 Reagents 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 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of 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
• The BD SARS-CoV-2 Reagents for BD MAX™ System are intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR, in vitro diagnostic procedures, and use of the BD MAX™ System
• Kit contains: (24) BD MAX™ ExK™ TNA-3 Sample Buffer Tubes, (24) BD MAX™ TNA Unitized Reagent Strips, (24) Extraction Tubes, (24) Tubes Reagent for BD MAX™ System Primers and Probes and (24) Tubes Dried PCR Master Mix

More Information

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