LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Approval order statement

Approval for the LIAISON XL MUREX HCV Ab. The LIAISON XL MUREX HCV Ab is an in vitro chemiluminescent immunoassay for the qualitative determination of specific antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric serum and plasma (lithium and sodium heparin, sodium citrate and potassium EDTA) samples including separator tubes, on the LIAISON XL Analyzer. It is intended to be used as an aid in the diagnosis of HCV infection. The assay may also be used as an aid in the diagnosis of HCV infection in pediatric subjects and in pregnant women. The test does not determine the state of infection or associated disease. The assay is not intended for use in screening blood, plasma, or tissue donors.The LIAISON XL MUREX Control HCV Ab (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON XL Murex HCV AB assay. The performance characteristics of LIAISON Controls have not been established for any other assays or instrument platforms different from LIAISON XL.