LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231214 FDA 510(k)
- FDA Product Code
- LFY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3900 FDA 510(k)
- Regulation Number
- 866.3900 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LIAISON VZV IgG HT is an enzyme-linked immunoabsorbent assay (ELISA) for in vitro qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum and plasma samples. It employs chemiluminescent immunoassay (CLIA) technology to support the differential diagnosis of VZV infection and assessment of immune status.
This assay is intended for use on the LIAISON automated platform and requires specific reagents for VZV IgG detection. Supplied as a single-use, non-sterile reagent kit, it is designed for microbiology laboratory settings. The device holds an FDA 510(k) clearance under classification II (device class 2) and is regulated under 21 CFR 866.3900. Storage and handling follow manufacturer guidelines for immunoassay reagents.
Frequently asked questions
What clinical purpose does the LIAISON VZV IgG HT test serve in a lab setting?
The LIAISON VZV IgG HT is designed to qualitatively detect specific IgG antibodies against varicella-zoster virus (VZV) in human serum or plasma. This helps differentiate between active VZV infection and past exposure, as well as assess a patient’s immune status to the virus. It’s particularly useful in microbiology labs for diagnosing VZV-related conditions like shingles or chickenpox.
How is the LIAISON VZV IgG HT supplied, and is it meant for single-use?
The LIAISON VZV IgG HT comes as a single-use, non-sterile reagent kit. Each kit is intended for one test run on the LIAISON automated platform, ensuring consistency and preventing cross-contamination. Since it’s single-use, leftover reagents cannot be reused after opening.
What platform does this test require, and does it include controls?
The LIAISON VZV IgG HT is exclusively designed for use on the LIAISON automated immunoassay platform. It includes a companion control, the LIAISON Control VZV IgG HT, which helps validate assay performance by confirming proper reagent function and instrument calibration before running patient samples.
How should the LIAISON VZV IgG HT reagents be stored, and are there special handling instructions?
Storage and handling follow standard immunoassay guidelines as outlined by the manufacturer. Since it’s a non-sterile reagent kit, it should be stored according to the provided instructions to maintain stability and accuracy. Avoid exposure to extreme temperatures, light, or contamination. Always refer to the included documentation for precise storage conditions and expiration details.
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: Varicella Zoster Diagnostics | Immunodiagnostics | Diasorin, LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214) — FDA 510(k ..., PDF K231214 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231214 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA 510(k) K231214 24 fields · synced Sep 19, 2026