Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor SpeeDx). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
Qualitative in vitro diagnostic tests that provide information about infection or exposure to Multiple Viruses. These devices are intended for use in hospital, reference or state laboratory settings. These devices are not intended for point of care use.