Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
Basic Information
- Device Name
- Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
- Trade Name
- LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
- PMA Number
- P180048
- Device Class
- FDA Class 3
- Product Code
- LOM
- Generic Name
- Test, hepatitis b (b core, be antigen, be antibody, b core igm)
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 29, 2020
- Date Received
- December 14, 2018
- Expedited Review
- N
- Docket Number
- 20M-1783
Advisory Committee Statement
Approval for the LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg. 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | FDA class 3 | Unknown |