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.
| Device | LIAISON XL MUREX anti-HBe, LIAISON XL MUREX Control anti-HBe |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc. |
| Date Received | 2018-12-19 |
| Decision Date | 2020-08-29 |
| PMA | P180049 |
| Supplement | S |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180049 | Original Filing | |
| S011 | 2022-11-10 | 30-day Notice |
| S010 | ||
| S009 | 2022-04-05 | Real-time Process |
| S008 | 2022-04-05 | 30-day Notice |
| S007 | 2022-02-04 | Real-time Process |
| S006 | 2021-11-23 | 30-day Notice |
| S005 | ||
| S004 | 2021-11-23 | 30-day Notice |
| S003 | ||
| S002 | 2021-05-27 | Real-time Process |
| S001 |