MEDTOX Diagnostics, Inc.
Burlington, NC, US
MEDTOX DIAGNOSTICS, INC. appears in FDA device records in Burlington, NC. FDA records list 22 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for MEDTOX Diagnostics, Inc. between 1998 and 2026. The busiest year on record is 2001, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 7 |
| 2002 | 2 |
| 2003 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | DJG | Substantially Equivalent | |
| K100951 | MEDTOX BUPRENORPHINE TEST | DJG | Substantially Equivalent | |
| K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM | DJG | Substantially Equivalent | |
| K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM | DJG | Substantially Equivalent | |
| K080635 | MEDTOXSCAN | DKZ | Substantially Equivalent | |
| K060351 | MEDTOX OXYCODONE | DJG | Substantially Equivalent | |
| K050394 | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS | DKZ | Substantially Equivalent | |
| K033334 | PROFILE -ER | DIS | Substantially Equivalent | |
| K031032 | VERDICT II, PROFILE II | DJG | Substantially Equivalent | |
| K022141 | VERDICT-II | DJC | Substantially Equivalent | |
| K020787 | VERDICT-II PROPOXYPHENE | JXN | Substantially Equivalent | |
| K011545 | VERDICT -II TCA, VERDICT-II MTD | LFG | Substantially Equivalent | |
| K010226 | VERDICT -II METHAMPHETAMINE | DJC | Substantially Equivalent | |
| K010959 | VERDICT -II BAR; VERDICT -II BZO | DIS | Substantially Equivalent | |
| K010564 | VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO | DKZ | Substantially Equivalent | |
| K010561 | VERDICT -II BAR/BZO | DIS | Substantially Equivalent | |
| K010138 | PROFILE II ER | LDJ | Substantially Equivalent | |
| K002331 | PROFILE-ER | DIS | Substantially Equivalent | |
| K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC | DKE | Substantially Equivalent | |
| K002776 | MODIFICATION TO PROFILE -II | LCM | Substantially Equivalent | |
| K992111 | VERDICT -II OPIATES 2000 | DJG | Substantially Equivalent | |
| K982211 | PROFILE-II MODEL 600582 | DKE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1050155 | 1050155 | MEDTOX DIAGNOSTICS, INC. | 1238 Anthony Rd, BURLINGTON, NC 27215 US | 2026 | and 8 more, listed in full below |
| 3004175381 | 3004175381 | MEDTOX DIAGNOSTICS, INC. | 1640 NOVA LANE, BURLINGTON, NC 27215 US | 2026 | and 8 more, listed in full below |
| 3011260354 | 3011260354 | MEDTOX Diagnostics, Inc. | 6624 Owens Drive, Pleasanton, CA 94588 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DIFDrug Mixture Control Materials
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
- JRCMicro Pipette
- OHQMulti-Analyte Controls Unassayed
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- DKEReagents, Test, Tetrahydrocannabinol
- POVSemen Analysis Device
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual
- DJCThin Layer Chromatography, Methamphetamine
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1329-2013 | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, | Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing. | Class II | Terminated | |
| Z-2202-2008 | MEDTOXscan Reader | Reader was marketed without a 510(k). | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain