Identifiers
- 510(k) Number
- K030649 FDA 510(k)
- FDA Product Code
- MRS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3220 FDA 510(k)
- Regulation Number
- 862.3220 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dri Cotinine Eia Assay is a liquid ready-to-use homogeneous enzyme immunoassay that uses specific antibodies to detect cotinine in urine. It is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase enzyme and free drug from the urine sample for a fixed amount of specific antibody binding sites. The assay is intended for in vitro diagnostic use only.
The Dri Cotinine Eia Assay is intended for the qualitative and semi-quantitative determination of cotinine in human urine at a cutoff level of 500 ng/mL. It is supplied as a liquid, ready-to-use homogeneous enzyme immunoassay and is regulated under FDA 510(k) and IVDD authorizations.
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: DRI COTININE EIA ASSAY by MICROGENICS CORP. | FDA 510(k) Summary, DRI COTININE EIA ASSAY (K030649) — FDA 510(k) | Innolitics, PDF DRI Cotinine Assay - Thermo Fisher Scientific
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K030649 | Class I | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K030649 24 fields · synced Sep 25, 2026
- EUDAMED 1 fields · synced Jun 2, 2026