Abusign(tm) Doa 4, Doa, Thc/Opi/Coc/Amp Or Met, Biosign(tm) Doa 4, Thc/Opi/Coc/…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K945549 FDA 510(k)
- FDA Product Code
- DIO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3250 FDA 510(k)
- Regulation Number
- 862.3250 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Abusign Doa 4, Doa, Thc/Opi/Coc/Amp or Met, Biosign Doa 4, Thc/Opi/Coc/Amp or Met is an Enzyme Immunoassay device for the detection of Cocaine and Cocaine Metabolites. It is a clinical toxicology test system.
The device is supplied by Princeton BioMeditech Corp. and is regulated under 21 CFR 862.3250 with the product code DIO. It was cleared by the FDA on October 26, 1995, with the K number K945549.
Frequently asked questions
What is the Abusign Doa 4 device used for?
The Abusign Doa 4 is used for the detection of Cocaine and Cocaine Metabolites, as part of a clinical toxicology test system.
How is the Abusign Doa 4 device supplied?
The device is supplied by Princeton BioMeditech Corp.
What is the regulatory classification of the Abusign Doa 4 device?
The device is regulated under 21 CFR 862.3250 with the product code DIO.
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: Abusign (Tm) Doa 4, Doa, Thc/Opi/Coc/Amp or Met, Biosign (Tm) Doa 4 ..., Abusign (tm) Doa 4, Doa, Thc/opi/coc/amp Or Met, Biosign (tm) Doa 4 ..., PDF K945549 - Abusign(Tm) Doa 4, Doa, Thc/Opi/Coc/Amp or Met, Biosign(Tm ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945549 | Class II | Active |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA 510(k) K945549 24 fields · synced Sep 22, 2026