LIAISON XL MUREX HBsAg Qual +2 more models
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P190017 FDA PMA
- FDA Product Code
- LOM FDA PMA
- Models / Variants
- LIAISON XL MUREX HBsAg Qual FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3172 FDA PMA
- Regulation Number
- 866.3172 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The LIAISON XL MUREX HBsAg Qual is an in vitro chemiluminescent immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma samples from adults and pediatric patients aged 2 to 21 years. The LIAISON XL MUREX HBsAg Confirmatory serves as a neutralization assay to confirm the presence of HBsAg in samples previously identified as reactive by the qualitative assay. Together, these tests aid in the diagnosis of hepatitis B virus (HBV) infection when used alongside clinical and serological information.
These assays are designed for use on the LIAISON XL Analyzer and are supplied as single-use reagents. The LIAISON XL MUREX Control HBsAg Qual (negative and positive) is intended exclusively for quality control monitoring of the qualitative assay. The devices are classified under FDA PMA (Premarket Approval) and fall under the microbiology category, adhering to regulatory standards for in vitro diagnostics. Storage and handling instructions are detailed in the Analyzer Operator’s Manual.
Frequently asked questions
What is the primary purpose of the LIAISON XL MUREX HBsAg Qual test, and how does it differ from the Confirmatory test?
The LIAISON XL MUREX HBsAg Qual is a chemiluminescent immunoassay designed for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma from patients aged 2 to 21 years, aiding in the diagnosis of HBV infection when combined with clinical and serological data. The Confirmatory test is a neutralization assay used only after a sample tests reactive in the Qual assay to confirm the presence of HBsAg, ensuring diagnostic accuracy. Together, they help rule out false positives and support HBV diagnosis.
What sample types and patient age ranges are approved for testing with the LIAISON XL MUREX HBsAg Qual?
The assay is approved for human serum and plasma, including samples collected in lithium heparin, sodium heparin, sodium citrate, and potassium EDTA tubes, as well as separator tubes. It is validated for use in adults and pediatric patients aged 2 to 21 years, though clinical judgment should guide interpretation in younger or high-risk populations.
Are the reagents for this test single-use, and how should they be stored?
Yes, the LIAISON XL MUREX HBsAg Qual and Confirmatory reagents are single-use only and must be used on the LIAISON XL Analyzer. Storage instructions are detailed in the Analyzer Operator’s Manual, but generally, reagents should be kept refrigerated (2–8°C) and protected from light until use, as per standard in vitro diagnostic practices.
What role does the LIAISON XL MUREX Control HBsAg Qual play in testing workflows, and is it compatible with other analyzers?
The LIAISON XL MUREX Control HBsAg Qual (negative and positive) is exclusively for quality control to monitor the performance of the Qual assay on the LIAISON XL platform. It is not validated for use with other analyzers or assay systems, including non-Diasorin platforms, ensuring accurate test reproducibility only on the designated system.
How is the regulatory approval status of these tests described, and what does it imply for clinical use?
The tests are approved under FDA Premarket Approval (PMA) with PMA number P190017, classified under microbiology (product code LOM). This implies a rigorous review process confirming safety, effectiveness, and performance for qualitative detection of HBsAg in specified patient populations, though clinical correlation with symptoms and other serological tests remains essential for diagnosis.
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: PDF Detection of Hepatitis B surface antigen (HBsAg) - SUMMARY OF SAFETY ..., Hepatitis Diagnostics Solutions | Immunodiagnostics | Diasorin, Hepatitis Diagnostics Solutions | Immunodiagnostics | Diasorin, LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190017 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P190017 24 fields · synced Oct 6, 2026