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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceLIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
DiaSorin Inc.
1951 northwestern avenue
stillwater, MN 55082
PMA NumberP180049
Date Received12/19/2018
Decision Date08/29/2020
Product Code LOM 
Docket Number 20M-1822
Notice Date 09/01/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  
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