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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 anti-HBe, LIAISON® XL MUREX Control anti-HBe
Generic NameQualitative and Quantitative Hepatitis B Virus Antibody assays
Regulation Number866.3173
ApplicantDiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082
PMA NumberP180049
Date Received12/19/2018
Decision Date08/29/2020
Reclassified Date10/20/2025
Product Code SEI 
Docket Number 20M-1822
Notice Date 09/01/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe. The LIAISON® XL MUREX Anti-HBe assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years) 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 hepatitis B (HBV) infection.This assay is not approved for use in screening blood, plasma or tissue donors. The LIAISON® XL MUREX Control Anti-HBe (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL MUREX Anti-HBe assay. The performance characteristics of LIAISON® XL MUREX Control Anti-HBe have not been established for any other assays or instrument platforms different from LIAISON® XL Analyzer.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S013 
S014 S015 S016 S017 S018 S019 S020 S021 
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