LIAISON XL MUREX Anti-HBc Assay and Control
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc FDA PMA
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA
Identifiers
- PMA Number
- P180038 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-HBc Assay is a chemiluminescent immunoassay (CLIA) for the qualitative detection of IgG and IgM (total) antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma. It is designed to aid in the diagnosis of hepatitis B virus (HBV) infection in patients with symptoms of hepatitis or those at risk, based on laboratory results and clinical information. The assay is not intended for blood, plasma, or tissue donor screening.
This device is supplied as a kit for use on the LIAISON XL Analyzer and includes a quality control component: the LIAISON XL MUREX Control Anti-HBc (negative and positive). The controls are intended solely for monitoring the performance of the Anti-HBc assay on this platform. The device holds an FDA Premarket Approval (PMA) under P180038 and is classified under device class II (866.3173) for microbiology applications. No regulatory status beyond the stated PMA is implied.
Frequently asked questions
What is the purpose of the LIAISON XL MUREX Anti-HBc assay?
The assay is designed to aid in the diagnosis of hepatitis B virus infection by detecting IgG and IgM antibodies to hepatitis B core antigen in human serum and plasma, based on laboratory results and clinical information.
What sample types are compatible with this assay?
The assay works with human adult and pediatric serum and plasma, including samples collected in lithium heparin, sodium heparin, sodium citrate, and K2 EDTA separator tubes.
Is this device intended for donor screening purposes?
No, the assay is not intended for use in screening blood, plasma, or tissue donors, as specified in its design and approval.
What components are included in the kit?
The kit includes the LIAISON XL MUREX Anti-HBc assay and the LIAISON XL MUREX Control Anti-HBc, which contains both negative and positive quality control samples.
What is the regulatory status of this device?
The device holds FDA Premarket Approval (PMA) under P180038 and is classified under device class II (866.3173) for microbiology applications.
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. Sources consulted: Hepatitis Diagnostics Solutions | Immunodiagnostics | Diasorin, Hepatitis Diagnostics Solutions | Immunodiagnostics | Diasorin, PDF Microsoft Word - P180038.SSED.FINAL.docx, LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180038 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P180038 24 fields · synced Oct 6, 2026