iFlash-HCG Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223690 FDA 510(k)
- FDA Product Code
- DHA FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iFlash-HCG Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a System, Test, Human Chorionic Gonadotropin device, classified under Clinical Chemistry. It performs chemiluminescence immunoassays to quantitatively measure human chorionic gonadotropin (hCG) levels in patient samples, aiding in the diagnosis and monitoring of conditions such as pregnancy and certain gynecological disorders.
This analyzer is designed for use in clinical chemistry laboratories and is supplied as a reusable instrument. It operates under FDA 510(k) clearance and IVDR compliance, with a traditional review pathway under the Clinical Chemistry advisory committee. The device is intended for professional medical settings and requires proper training for operation. Storage and maintenance follow manufacturer guidelines to ensure accuracy and reliability.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223690 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
Sources (2)
- FDA 510(k) K223690 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026