CEDIA DAU Benzodiazepine Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K942795 FDA 510(k)
- FDA Product Code
- JXM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3170 FDA 510(k)
- Regulation Number
- 862.3170 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA DAU Benzodiazepine Assay is an enzyme immunoassay designed for the qualitative detection of benzodiazepines in biological samples. It employs a chemiluminescent enzyme donor immunoassay (CEDIA) technique to identify the presence of benzodiazepine compounds, aiding in clinical toxicology assessments.
This assay is supplied as a reagent kit for in vitro diagnostic use, intended for single-use only. It is classified as a Class II device under FDA regulations and has received both FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization. The kit requires storage under specified conditions to maintain integrity and is used in clinical settings for diagnostic purposes, adhering to regulatory compliance standards.
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 | K942795 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K942795 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026