• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
DeviceLIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
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
Supplements:  
-
-