Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Abbott Australasia Pty Ltd Molecular Division). ARTG record,…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2), and Varicella Zoster Virus (VZV) DNA from clinician-collected lesion swab specimens (including cutaneous or mucocutaneous lesion specimens). The Alinity m HSV 1 & 2 / VZV assay is intended for use as an aid in the diagnosis of HSV-1, HSV-2 and/or VZV infections in symptomatic patients.