LIAISON XL MUREX anti-HBe, LIAISON XL MUREX Control anti-HBe

FDA Premarket Approval P180049

Pre-market Approval Supplement Details

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.

DeviceLIAISON XL MUREX anti-HBe, LIAISON XL MUREX Control anti-HBe
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.
Date Received2018-12-19
Decision Date2020-08-29
PMAP180049
SupplementS
Product CodeLOM 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082

Supplemental Filings

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Supplement NumberDateSupplement Type
P180049Original Filing

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