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| Device | LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe |
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| Generic Name | test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant |
| DiaSorin Inc. |
| 1951 northwestern avenue |
| stillwater, MN 55082 |
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| PMA Number | P180049 |
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| Date Received | 12/19/2018 |
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| Decision Date | 08/29/2020 |
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| Product Code |
LOM
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| Docket Number | 20M-1822 |
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| Notice Date | 09/01/2020 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe. 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. |
| Approval Order |
Approval Order
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| Summary |
Summary of Safety and Effectiveness |
| Labeling |
Labeling
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| Supplements: |
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