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Premarket Approval (PMA)

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Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
DiaSorin Inc.
1951 northwestern avenue
stillwater, MN 55082
PMA NumberP180048
Date Received12/14/2018
Decision Date08/29/2020
Product Code LOM 
Docket Number 20M-1783
Notice Date 09/01/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg. The LIAISON® XL MUREX HBeAg assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of hepatitis B virus (HBV) e antigen (HBeAg) in human adult and pediatric (2-21 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.The assay is not intended for use in screening blood, plasma, or tissue donors.The LIAISON® XL MUREX Control HBeAg (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL MUREX HBeAg assay. The performance characteristics of LIAISON® XL MUREX Control HBeAg have not been established for any other assays or instrument platforms.
Approval Order Approval Order
Labeling Labeling