Device Dossier
Multiple infectious organism IVDs
Device Dossier for Multiple infectious organism IVDs (CT923 - Multiple infectious organism IVDs, Class 2, sponsor SpeeDx). ARTG record, intended purpose,…
- GMDN category: CT923 - Multiple infectious organism IVDs
Intended purpose
The Positive Control HSV/VZV/TP swab is formulated with inactivated herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), varicella zoster virus (VZV) and cells containing Treponema pallidum (etiologic agent of syphilis) genome. The Positive Control HSV/VZV/TP kit can be used as a full process control with nucleic acid detection assays, for use from sample extraction and purification to amplification and detection.