EliA SymphonyS Immunoassay
FDA 510(k)Class II (US FDA 510(k))
by Phadia AB
Identifiers
- 510(k) Number
- K190710 FDA 510(k)
- FDA Product Code
- LLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EliA SymphonyS Immunoassay is an automated in vitro diagnostic immunoassay for detecting antinuclear IgG antibodies. It uses the EliA IgG method on the Phadia 2500/5000 instrument. The device is designed to process human serum or plasma samples collected in Li-heparin or EDTA tubes.
The EliA SymphonyS Immunoassay is supplied as a Class II device under product code LLL, classified as Extractable Antinuclear Antibody, Antigen And Control with Special Controls. It is manufactured by Phadia AB in Uppsala, Sweden, and received FDA 510(k) clearance on November 29, 2019. The device is intended for laboratory use and requires appropriate storage conditions as specified by the manufacturer.
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: EliA SymphonyS Well - Thermo Fisher Scientific, EliA SymphonyS Immunoassay (K190710) — FDA 510(k) | Innolitics, K190710 - EliA SymphonyS Immunoassay | FDA 510(k) | Phadia AB, Phadia™ Laboratory Systems - Thermo Fisher Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190710 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (1)
- FDA 510(k) K190710 24 fields · synced Sep 22, 2026