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
IVD assays for the direct qualitative detection and differentiation of multiple viral infections from, for example assays for enteric viral pathogens or for respiratory viral pathogens. The IVD assays are performed using specified specimen types, utilising real-time polymerase chain reaction for the amplification of relevant gene target DNA/RNA.