Rubella IgM ELISA Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K914028 FDA 510(k)
- FDA Product Code
- LFX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3510 FDA 510(k)
- Regulation Number
- 866.3510 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rubella IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of IgM antibodies to rubella virus in human serum. It is used to evaluate serologic evidence of active or recent infection with rubella virus and is for in vitro diagnostic use.
The test system is supplied as a kit for laboratory use and requires handling by trained personnel. It is classified as a Class II medical device under FDA regulation 866.3510 and was cleared via the traditional 510(k) pathway (K914028). The device is intended for in vitro diagnostic use only and is not sterile or implantable.
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: Rubella IgM Test System - ZEUS Scientific, PDF Rubella IgM Test System - Zeus Scientific, Inc, ZEUS SCIENTIFIC, INC. 9Z9801M ELISA Rubella IgM Test System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914028 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K914028 24 fields · synced Oct 1, 2026