LIAISON XL MUREX Anti-HBe and Control Anti-HBe
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe FDA PMA
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA
Identifiers
- PMA Number
- P180049 FDA PMA
- FDA Product Code
- SEI FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3173 FDA PMA
- Regulation Number
- 866.3173 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The LIAISON XL MUREX Anti-HBe and Control Anti-HBe are in vitro chemiluminescent immunoassays (CLIA) for the qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human serum and plasma (lithium heparin, sodium citrate, and K2 EDTA), including separator tubes. The assay is designed for use on the LIAISON XL Analyzer and supports diagnostic evaluation of hepatitis B virus (HBV) infection in adult and pediatric patients aged 2 to 21 years. The Control Anti-HBe serves as a quality control sample to monitor assay performance, ensuring reliability of results.
The LIAISON XL MUREX Anti-HBe and Control Anti-HBe are intended for laboratory use only and are not approved for screening blood, plasma, or tissue donors. Supplied as single-use reagents, they require storage and handling according to manufacturer guidelines. The device is authorized under an FDA Premarket Approval (PMA) and classified under device class II (866.3173). Performance characteristics are established exclusively for the LIAISON XL Analyzer platform.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180049 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P180049 24 fields · synced Oct 6, 2026