Identifiers
- 510(k) Number
- K905689 FDA 510(k)
- FDA Product Code
- DIP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3350 FDA 510(k)
- Regulation Number
- 862.3350 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA Phenytoin Assay is an enzyme immunoassay designed for the quantitative measurement of phenytoin in biological samples. It employs chemiluminescent enzyme donor immunoassay (CEDIA) technology to detect and quantify free phenytoin levels, aiding in the monitoring of therapeutic drug concentrations in clinical toxicology settings.
This assay is supplied as a ready-to-use diagnostic reagent kit for in vitro laboratory use. It is intended for single-use and requires no additional sterilisation, with compliance to both FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD) regulations. The device is classified under Class II (device class 2) and is distributed in various kit sizes and configurations, as indicated by the registration numbers. Storage and handling follow standard laboratory protocols for immunoassay reagents.
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
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K905689 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K905689 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026