HSA · registration DE0510386BD Respiratory Viral Panel for BD MAX™ System
- Registration number
- DE0510386
- Model name
- BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel for BD MAX™ System
- Model identifier
- 445215; 445373
- Registration date
- February 25, 2025
- Source update date
- November 19, 2025
- Risk class
- Class D
- Product owner
- Becton, Dickinson and Company
- Registrant / registration holder
- BECTON DICKINSON HOLDINGS PTE. LTD.
BD Respiratory Viral Panel for BD MAX™ System is an automated multiplexed real-time RT-PCR test intended for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in nasopharyngeal and anterior nasal swabs collected from individuals suspected of respiratory viral infection consistent with COVID-19, flu, or respiratory syncytial virus related symptoms by a healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and respiratory syncytial virus can be similar.
- Product owner address
- 7 Loveton Circle, Sparks, Maryland, 21152, United States
- Registrant address
- 10 COLLYER QUAY, #10-01, OCEAN FINANCIAL CENTRE, Singapore 049315
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.