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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.
 
DeviceLIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDiaSorin Inc
1951 Northwestern Avenue
Stillwater, MN 55082
PMA NumberP190017
Date Received06/28/2019
Decision Date08/29/2020
Product Code LOM 
Docket Number 20M-1829
Notice Date 09/01/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test. The LIAISON® XL MUREX HBsAg Qual assay is an in vitro chemiluminescent immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 to 21 years) serum and plasma (lithium and sodium heparin, sodium citrate and potassium EDTA) including separator tubes, on the LIAISON® XL Analyzer. Assay results in conjunction with other hepatitis B virus (HBV) serological and clinical information, may be used as an aid in the diagnosis of HBV infection in patients with symptoms of hepatitis or who may be at risk for HBV infection. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period.The LIAISON® XL MUREX Control HBsAg Qual (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL MUREX HBsAg Qual assay. The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL.For details, refer to the Analyzer Operator's Manual.The LIAISON® XL MUREX HBsAg Confirmatory is an in vitro neutralization assay for confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma samples found repeatedly reactive for HBsAg by the LIAISON® XL MUREX HBsAg Qual ([REF] 318250).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S005 S006 S004 S011 S014 S015 S020  S008 S002 S012 S003 
S009 S010 S019 S021 S022 S017 S016 
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