LIAISON XL MUREX HBc IgM, LIAISON MUREX Control HBc IgM

FDA Premarket Approval P180045

Pre-market Approval Supplement Details

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.

DeviceLIAISON XL MUREX HBc IgM, LIAISON MUREX Control HBc IgM
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.
Date Received2018-12-06
Decision Date2020-08-29
PMAP180045
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
P180045Original Filing

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