Identifiers
- 510(k) Number
- K945344 FDA 510(k)
- FDA Product Code
- DIS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3150 FDA 510(k)
- Regulation Number
- 862.3150 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cedia Dau Barbiturate Assay is an enzyme immunoassay for barbiturate. It is classified as a Class II device with special controls.
The device is supplied by Microgenics Corporation and has been cleared by the FDA. It is intended for use in clinical toxicology settings and is available with various registration numbers, including 3010934853 and 3031697086. The device is regulated under regulation number 862.3150 and has a product code of DIS.
Frequently asked questions
What is the Cedia Dau Barbiturate Assay used for?
The Cedia Dau Barbiturate Assay is used for the detection of barbiturate in clinical toxicology settings.
Is the Cedia Dau Barbiturate Assay cleared by the FDA?
Yes, the Cedia Dau Barbiturate Assay has been cleared by the FDA under regulation number 862.3150.
What type of device is the Cedia Dau Barbiturate Assay?
The Cedia Dau Barbiturate Assay is classified as a Class II device with special controls, and is an enzyme immunoassay.
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: K936030 FDA 510 (k) - CEDIA DAU BARBITURATE ASSAY, CEDIA DAU BARBITURATE ASSAY (K942436) — FDA 510(k) | Innolitics, Cedia (R) Dau Barbiturate Assay, Modification, PDF K945344 - Cedia Dau Barbiturate Assay, CEDIA Barbiturate Assay - MedEquip Directory
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945344 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K945344 24 fields · synced Oct 1, 2026