Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Becton Dickinson). ARTG record, intended purpose, GMDN category…
- GMDN category: CT702 - Multiple-viruses IVDs
- Sponsor: Becton Dickinson
Intended purpose
VIASURE Real Time PCR Detection IVDs are designed for the identification and differentiation of Influenza A, Influenza B (Flu A and/or B) and/or Human Respiratory Syncytial Virus (RSV) and/or SARS-CoV-2 in respiratory samples as an aid to diagnosis along with other clinical and epidemiological risk factors from patients with signs and symptoms of respiratory infection.