Device Dossier
Hepatitis B virus IVDs
Device Dossier for Hepatitis B virus IVDs (CT704 - Hepatitis B virus IVDs, Class 3, sponsor Hologic (Australia & New Zealand)). ARTG record, intended…
- GMDN category: CT704 - Hepatitis B virus IVDs
Intended purpose
The Aptima HBV Quant assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system and is intended for use as an aid in the management of patients with chronic HBV infections undergoing HBV antiviral drug therapy.