Molecular Reagent BD MAX™ SARS-CoV-2, Influenza A / B, Respiratory Syncytial Virus (RSV) CLIA Non-Waived For BD MAX System 2,400 Tests

Features

• BD MAX RVP, 100 pack, 2,400 Test Kit
• BD Respiratory Viral Panel for BD MAX System is for use under an FDA EUA: 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
• This test is authorized for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in nasopharyngeal and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19
• Emergency use of this test is limited to authorized laboratories
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests
• Positive results are indicative of nucleic acid but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
• Negative results do not preclude SARS-CoV-2, influenza A, influenza B, and/or RSV 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/or epidemiological information
• Kit contents: (24) Tubes BD Respiratory Viral Panel System Master Mix, (24) Tubes System Extraction Tubes, (24) Unitixed Reagent Strips, (24) BD Molecular RVP Sample Buffer Tubes
• Required but not Provided: BD MAX™ System with Software Version 5.14 or later (BD Catalog Number 441916), BD MAX™ Sample Rack (BD Catalog Number 444807 or 444808), BD PCR Cartridges (BD Catalog Number 437519)

More Information

• BD MAX Respiratory Viral Panel FDA EUA Letter
• BD MAX Respiratory Viral Panel IFU
• BD Max Respiratory Viral Panel Healthcare Providers Fact Sheet
• BD Max Respiratory Viral Panel Patients Fact Sheet