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Singapore HSA registration DE0510386

BD Respiratory Viral Panel for BD MAX™ System

Singapore flagSingapore·CLASS D IVD·Becton, Dickinson and Company·Registered February 25, 2025
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0510386
Registration Date
February 25, 2025
Retention Due Date
February 24, 2026
Product description
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
Name
Becton, Dickinson and Company
Short Name
Becton, Dickinson and Company
Address
7 Loveton Circle, Sparks, Maryland, 21152, UNITED STATES
Registrant
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Name
BECTON DICKINSON HOLDINGS PTE. LTD.
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
Model Name(s)
BD Respiratory Viral Panel for BD MAX™ System
Model Identifier(s)
445215
About this record

Access comprehensive regulatory information for BD Respiratory Viral Panel for BD MAX™ System in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0510386 and owned by Becton, Dickinson and Company. The device was registered on February 25, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD