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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 Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDiaSorin Inc.
1951 northwestern avenue
stillwater, MN 55082
PMA NumberP180038
Date Received09/26/2018
Decision Date01/02/2020
Product Code LOM 
Docket Number 20M-0107
Notice Date 01/08/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the LIAISON XL MUREX Anti-HBc assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of IgG and IgM (total) antibodies to hepatitis B core antigen (anti-HBc) in human adult and pediatric serum and plasma (lithium and sodium heparin, sodium citrate and K2 EDTA) including separator tubes, on the LIAISON XL Analyzer. Assay results in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B virus (HBV) infection in patients with symptoms of hepatitis or who may be at risk for HBV infection. The assay is not intended for use in screening blood, plasma or tissue donors. The LIAISON XL MUREX Control Anti-HBc (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON XL MUREX Anti-HBc assay. The performance characteristics of LIAISON XL MUREX Control Anti-HBc have not been established for any other assays or instrument platforms.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011