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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantDiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285
PMA NumberP190011
Date Received04/22/2019
Decision Date10/18/2019
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S004