Aptus Automated Application of the VZV IgG ELISA Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K984181 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 Aptus Automated Application of the VZV IgG ELISA Test System is an enzyme-linked immunosorbent assay designed for the qualitative detection of Varicella-Zoster Virus IgG antibodies in human serum. This test system is used to aid in the diagnosis of VZV infections and the determination of immune status.
This device is manufactured by Zeus Scientific, Inc. and has received FDA 510(k) clearance. It is classified as a microbiology device under regulation number 866.3900.
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: The Aptus (Automated) Application of The Vzv Igg Elisa Test System ..., The Aptus (Automated) Application of The Vzv Igg Elisa Test System, PDF K984181 the Aptus (Automated) Application of The Vzv Igg Elisa Test System, VZV IgG Test System - ZEUS Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984181 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K984181 24 fields · synced Oct 6, 2026