Identity
- Trade Name
- AB -HAVK FDA PMA
- Generic Name
- Hepatitis a test (antibody and igm antibody) FDA PMA
Identifiers
- PMA Number
- P890019 FDA PMA
- FDA Product Code
- LOL FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3310 FDA PMA
- Regulation Number
- 866.3310 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Diasorin ETI-AB-HAVK Plus is a qualitative immunoassay for the detection of total antibodies to hepatitis A virus (anti-HAV) in human serum or plasma. Classified under microbiology, it identifies both IgG and IgM antibodies, aiding in the diagnosis of hepatitis A infection or immune status assessment.
This device is supplied as a reagent kit for use with the automated LIAISON® Analyzer system and is intended for in vitro diagnostic use. It is not classified as single-use or reusable but requires adherence to standard laboratory protocols for sample handling and assay performance. The product holds FDA Premarket Approval (PMA) under number P890019, with subsequent supplements, and is regulated under FDA classification for microbiology diagnostics.
Frequently asked questions
What clinical purpose does the Diasorin ETI-AB-HAVK Plus serve in diagnosing hepatitis A infections?
The ETI-AB-HAVK Plus detects total antibodies (including both IgG and IgM) to hepatitis A virus (HAV) in human serum or plasma. This helps clinicians determine whether a patient has an active infection (IgM antibodies), past exposure (IgG antibodies), or is immune due to vaccination or prior infection. It aids in assessing immune status and diagnosing acute or chronic hepatitis A exposure.
How is the ETI-AB-HAVK Plus supplied, and what system is required for use?
The device is supplied as a reagent kit designed exclusively for use with the automated LIAISON® Analyzer system. It is not a standalone test but requires integration with this analyzer for processing samples. The kit follows standard laboratory protocols for sample handling and assay performance.
Is the ETI-AB-HAVK Plus intended for single-use or repeated use in a clinical setting?
The ETI-AB-HAVK Plus is not classified as single-use or reusable—it is a reagent kit meant for use within the LIAISON® system. Its usability depends on adherence to the manufacturer’s instructions for sample preparation and assay protocols, which dictate proper handling and disposal to maintain accuracy and prevent cross-contamination.
What regulatory pathway does the ETI-AB-HAVK Plus follow, and how does this affect its use?
The ETI-AB-HAVK Plus holds FDA Premarket Approval (PMA) under number P890019, with subsequent supplements. This approval ensures it meets stringent regulatory standards for in vitro diagnostic devices, particularly for microbiology applications. Clinicians and labs should confirm compliance with the PMA requirements and follow the manufacturer’s guidelines for proper use and interpretation of 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: Ab-havk, Eti-ab-havk, Eti-ab-havk Plus PMA P890019S005 - FDA.report, DIASORIN ETI-AB-HAVK PLUS PMA P890019S011 - FDA.report, PDF DEC 0 5 2008 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P890019 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin
Sources (1)
- FDA PMA P890019 24 fields · synced Sep 18, 2026