Identity
- Trade Name
- LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab FDA PMA
- Generic Name
- Assay, enzyme linked immunosorbent, hepatitis c virus FDA PMA
Identifiers
- PMA Number
- P190011 FDA PMA
- FDA Product Code
- MZO FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3169 FDA PMA
- Regulation Number
- 866.3169 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The LIAISON XL MUREX HCV Ab Assay is an in vitro chemiluminescent immunoassay for the qualitative detection of specific antibodies to hepatitis C virus (anti-HCV) in human serum and plasma samples, including those from separator tubes. Classified as an enzyme-linked immunosorbent assay, it aids in the diagnosis of hepatitis C virus infection in adult and pediatric populations, as well as in pregnant women, though it does not determine infection status or associated disease severity.
This assay is designed for use on the LIAISON XL Analyzer and is supplied as a reagent kit for laboratory testing. It is intended for single-use and requires no sterilisation beyond manufacturer-provided packaging. The device is regulated under FDA Premarket Approval (PMA) with approval number P190011, adhering to classification MZO and regulation 866.3169. Quality control is supported by the LIAISON XL MUREX Control HCV Ab (negative and positive), validated exclusively for this assay and 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 | P190011 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P190011 23 fields · synced Oct 6, 2026