LIAISON XL MUREX HBsAg Qual, LIAISON MUREX Control HBsAg, and LIAISON XL MUREX HBsAg Confirmatory Test

FDA Premarket Approval P190017

Pre-market Approval Supplement Details

The liaison® xl murex hbsag qual assay is an in vitro chemiluminescent immunoassay for the qualitative detection of hepatitis b surface antigen (hbsag) in human adult and pediatric (2 to 21 years) serum and plasma (lithium and sodium heparin, sodium citrate and potassium edta) including separator tubes, on the liaison® xl analyzer. Assay results in conjunction with other hepatitis b virus (hbv) serological 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 assay may also be used to screen for hbv infection in pregnant women to identify neonates who are at risk for acquiring hepatitis b during the perinatal period. The liaison® xl murex control hbsag qual (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the liaison® xl murex hbsag qual assay. The performance characteristics of liaison® controls have not been established for any other assays or instrument platforms different from liaison® xl. For details, refer to the analyzer operator's manual. The liaison® xl murex hbsag confirmatory is an in vitro neutralization assay for confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma samples found repeatedly reactive for hbsag by the liaison® xl murex hbsag qual ([ref] 318250).

DeviceLIAISON XL MUREX HBsAg Qual, LIAISON MUREX Control HBsAg, and LIAISON XL MUREX HBsAg Confirmatory Test
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc
Date Received2019-06-28
Decision Date2020-08-29
PMAP190017
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
P190017Original Filing

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