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.
| Device | LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc. |
| Date Received | 2018-12-14 |
| Decision Date | 2020-08-29 |
| PMA | P180048 |
| 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 |
|---|---|---|
| P180048 | 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 | 2021-11-23 | 30-day Notice |
| S004 | 2021-11-23 | 30-day Notice |
| S003 | ||
| S002 | 2021-05-27 | Real-time Process |
| S001 |