Reagent Kit BD MAX™ Real Time RT-PCR SARS-CoV-2 For BD MAX System 24 Tests

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