Device Category Dossier

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Device Category Dossier for Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT). Australian ARTG records, sponsors, device class —…

Device: 411530 - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device: cobas HCV (cobas 5800/6800/8800) - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device: Xpert HCV VL - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device: Alinity m HCV assay - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device: GXHCV-FS-CE-10 - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device: cobas HCV for use on the cobas 4800 System - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device: APTIMA HCV QUANT DX ASSAY KIT - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Hepatitis

C virus nucleic acid in vitro diagnostic devices are nucleic acid amplification tests that detect and quantitate hepatitis C virus RNA in human serum, plasma, or whole blood specimens using reverse transcription-polymerase chain reaction methodology. These tests are used to aid in the diagnosis of hepatitis C infection in anti-HCV positive individuals and at-risk populations, and to monitor viral load in patients undergoing antiviral therapy.