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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 HBc IgM, LIAISON® XL MUREX Control HBc IgM
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDiaSorin Inc.
1951 northwestern avenue
stillwater, MN 55082
PMA NumberP180045
Date Received12/06/2018
Decision Date08/29/2020
Product Code LOM 
Docket Number 20M-1828
Notice Date 09/03/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM. The LIAISON® XL MUREX HBc IgM assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of IgM antibodies to hepatitis B virus core antigen (HBc IgM) 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 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 presence of anti-HBc IgM is indicative of acute or recent HBV infection.This assay is not approved for use in screening blood, plasma or tissue donors. The LIAISON® XL MUREX Control HBc IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL MUREX HBc IgM assay. The performance characteristics of LIAISON® XL MUREX Control HBc IgM have not been established for any other assays or instrument platforms.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 S005 S006 S007 S008 
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