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Sign in to claim this brandMEDTOX DIAGNOSTICS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1238 Anthony Rd, BURLINGTON, NC, 27215
- Website
- medtoxdiagnostics.com
- —
- —
- [email protected]
- Phone
- 877-643-5703
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1050155
- DUNS Number
- 137417965
Catalogue (103)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Modification To Profile -ii | K002776 | FDA 510(k) | U | Active |
| Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids | K050394 | FDA 510(k) | Class II | Active |
| Profile-Ii Model 600582 | K982211 | FDA 510(k) | Class II | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 5, 2013 | Z-1329-2013 | — | terminated | Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing. |
| Feb 8, 2008 | Z-2202-2008 | — | terminated | Reader was marketed without a 510(k). |