Medtox Diagnostics, Inc.
Medical device manufacturer in Burlington, NC.
22510(k) clearances
0PMA approvals
2recalls
Device types
- DJG Enzyme Immunoassay, Opiates 7
- DIS Enzyme Immunoassay, Barbiturate 4
- DKZ Enzyme Immunoassay, Amphetamine 3
- DKE Reagents, Test, Tetrahydrocannabinol 2
- DJC Thin Layer Chromatography, Methamphetamine 2
- LCM Enzyme Immunoassay, Phencyclidine 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- LFG Radioimmunoassay, Tricyclic Antidepressant… 1
- JXN Enzyme Immunoassay, Propoxyphene 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | 01/29/2026SE |
| K100951 | Medtox Buprenorphine TestDJG · Traditional | 10/18/2010SE |
| K100023 | Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemDJG · Traditional | 04/05/2010SE |
| K091454 | Profile-V Medtoxscan Drugs of Abuse Test SystemDJG · Traditional | 07/24/2009SE |
| K080635 | MedtoxscanDKZ · Traditional | 02/13/2009SE |
| K060351 | Medtox OxycodoneDJG · Traditional | 05/12/2006SE |
| K050394 | Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone…DKZ · Traditional | 10/25/2005SE |
| K033334 | Profile -ErDIS · Special | 11/10/2003SE |
| K031032 | Verdict II, Profile IIDJG · Special | 07/14/2003SE |
| K022141 | Verdict-IiDJC · Special | 07/30/2002SE |
| K020787 | Verdict-Ii PropoxypheneJXN · Traditional | 05/02/2002SE |
| K011545 | Verdict -Ii Tca, Verdict-Ii MTDLFG · Special | 06/08/2001SE |
| K010226 | Verdict -Ii MethamphetamineDJC · Traditional | 06/01/2001SE |
| K010959 | Verdict -Ii Bar; Verdict -Ii BzoDIS · Special | 04/13/2001SE |
| K010564 | Verdict -Ii Thc/Coc/Opi/Amp/Pcp/Bar/Bzo & Thc/Coc/Bar/Bzo; Profile -Ii 7…DKZ · Special | 04/05/2001SE |
| K010561 | Verdict -Ii Bar/BzoDIS · Special | 04/05/2001SE |
| K010138 | Profile II ErLDJ · Special | 02/14/2001SE |
| K002331 | Profile-ErDIS · Traditional | 01/17/2001SE |
| K003687 | Verdict II Thc/Coc/Opi/Amp, Verdictii Thc/Coc/Opi,Verdict II Thc/Coc/Amp,Verdict II…DKE · Special | 12/22/2000SE |
| K002776 | Modification to Profile -IiLCM · Special | 09/28/2000SE |
| K992111 | Verdict -Ii Opiates 2000DJG · Traditional | 12/16/1999SE |
| K982211 | Profile-Ii Model 600582DKE · Traditional | 07/29/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1329-2013 Class II | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of…Review of validation information and customer complaints which indicated preliminary screen positive results… | 04/05/2013Terminated |
| Z-2202-2008 | MEDTOXscan ReaderReader was marketed without a 510(k). | 02/08/2008Terminated |