Device Dossier
Alinity m HCV assay - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Dossier for Alinity m HCV assay - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) (Hepatitis C virus nucleic acid IVD, kit,…
Intended purpose
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
Functional description
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.