LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P180048 FDA PMA
- FDA Product Code
- LOM 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 HBeAg is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of hepatitis B virus e antigen (HBeAg) in human serum and plasma samples, including lithium and sodium heparin, sodium citrate, and K2 EDTA, as well as separator tubes. It is designed for use on the LIAISON XL Analyzer and aids in the diagnosis of hepatitis B virus (HBV) infection in patients with symptoms or risk factors. The LIAISON XL MUREX Control HBeAg serves as a quality control sample to monitor the performance of the HBeAg assay, ensuring accurate results for clinical decision-making.
This device is intended for use in clinical microbiology laboratories and is supplied as a reagent kit for the LIAISON XL Analyzer. The assay is not intended for blood, plasma, or tissue donor screening. The LIAISON XL MUREX HBeAg and its control are approved under FDA PMA (P180048) and are classified as a Class II medical device (product code LOM). The controls are not validated for use with other assay platforms. The device requires proper storage and handling as per manufacturer instructions to maintain performance integrity.
Frequently asked questions
What types of samples can the LIAISON XL MUREX HBeAg test, and why is this important for clinical use?
The LIAISON XL MUREX HBeAg is designed to detect hepatitis B virus e antigen (HBeAg) in human serum and plasma, including samples collected with lithium heparin, sodium heparin, sodium citrate, K2 EDTA, and separator tubes. This versatility is important because it allows clinicians to use a variety of commonly collected specimen types for testing, ensuring flexibility in diagnostic workflows. The assay is not intended for blood, plasma, or tissue donor screening, which clarifies its intended clinical use in diagnosing HBV infection in symptomatic patients or those at risk.
How is the LIAISON XL MUREX HBeAg supplied, and what role does the control play in ensuring accurate results?
The LIAISON XL MUREX HBeAg is supplied as a reagent kit specifically for use on the LIAISON XL Analyzer. The accompanying LIAISON XL MUREX Control HBeAg (both negative and positive controls) is critical for monitoring assay performance. These controls help validate the accuracy and reliability of the test results, ensuring that the diagnostic process remains dependable for clinical decision-making. The controls are *not* interchangeable with other assay platforms, so they must be used exclusively with this system.
Is the LIAISON XL MUREX HBeAg intended for pediatric patients, and if so, what age range is supported?
Yes, the LIAISON XL MUREX HBeAg is approved for use in both adult and pediatric patients aged 2 to 21 years. This broader age range ensures that clinicians can rely on the assay for diagnosing HBV infection across a wide patient population, including children who may exhibit symptoms or risk factors for hepatitis B.
What storage and handling requirements must be followed to maintain the performance integrity of the LIAISON XL MUREX HBeAg and its controls?
While the exact storage conditions are not detailed in the provided data, the manufacturer’s instructions must be followed to preserve the assay’s performance. Proper storage is essential because improper handling—such as exposure to extreme temperatures or light—could compromise the chemiluminescent immunoassay’s sensitivity or stability. Always refer to the included documentation for specific guidelines on refrigeration, expiration, and handling protocols to ensure accurate and reliable test results.
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: LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe, LIAISON® XL MUREX HBeAg assay and Control PMA… - FDA.report, LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180048 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P180048 24 fields · synced Oct 6, 2026