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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-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDiaSorin Inc.
1951 northwestern avenue
stillwater, MN 55082
PMA NumberP180039
Date Received09/26/2018
Decision Date02/21/2020
Product Code LOM 
Docket Number 20M-0984
Notice Date 02/26/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the LIAISON XL MUREX Anti-HBs. The device is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative and quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human adult and pediatric (2 – 21 years) serum and plasma (lithium and sodium heparin and K2 EDTA) including separator tubes, on the LIAISON XL Analyzer. Assay results in conjunction with other hepatitis B virus (HBV) serological markers 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 results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. The assay is not approved for use in screening blood, plasma or tissue donors. The LIAISON XL MUREX Control Anti-HBs (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON XL MUREX Anti-HBs assay. The performance characteristics of LIAISON XL MUREX Control Anti-HBs have not been established for any other assays or instrument platforms.The LIAISON XL MUREX Anti-HBs Verifiers (level 1, 2, 3, and level 4) are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON XL MUREX Anti-HBs assay. The performance characteristics of LIAISON XL MUREX Anti-HBs Verifiers have not been established in connection with any other assay or instrument platforms.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 
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