Molecular Reagent BD MAX™ Respiratory Viral Panel (RVP) CLIA Non-Waived For BD MAX System 24 Tests

Features

• BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT- PCR) test intended for the simultaneous, qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection
• The test uses a single nasal swab or a single nasopharyngeal swab sample to determine if a patient has COVID-19 or the flu or RSV
• BD Respiratory Viral Panel for BD MAX™ System is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and/or RSV infection if used in conjunction with other clinical and epidemiological information, and laboratory findings
• Positive results do not rule out co-infection with other organisms; the agent(s) detected by the BD Respiratory Viral Panel for BD MAX™ System may not be the definitive cause of disease
• Negative results do not preclude SARS-CoV-2, influenza A, influenza B, and/or RSV infection
• Materials provided: 2 X 12 Tubes BD Respiratory Viral Panel for BD MAX™ System Master Mix (F4), 2 X 12 Tubes BD RVP for BD MAX™ System Extraction Tube (D4), 24 Tests BD RVP for BD MAX™ System Unitized Reagent Strip, 2 X 12 BD Molecular RVP Sample Buffer Tubes
• Required but not provided: BD MAX™ System (BD Catalog Number 441916)

More Information

• BD MAX RVP 510k IFU
• SDS