MEDTOXScan® Reader
GUDID 00690286000063
An instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Devices, which are one-step immunochromatographic tests for the rapid, qualitative detection of one or more drugs in human urine.
MEDTOX DIAGNOSTICS, INC.
Multiplex analyser IVD, laboratory, semi-automated| Primary Device ID | 00690286000063 |
| NIH Device Record Key | 7ca1f86b-daa8-400c-81c3-56e2b401c8b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDTOXScan® Reader |
| Version Model Number | 833073 |
| Company DUNS | 137417965 |
| Company Name | MEDTOX DIAGNOSTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com | |
| Phone | 877-643-5703 |
| techservices@medtoxdiagnostics.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690286000063 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080635
FDA Product Code
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by MEDTOX DIAGNOSTICS, INC.
| 10690286000756 - PROFILE®-V MEDTOXScan® | 2023-08-09 A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamp |
| 10690286000763 - PROFILE®-V MEDTOXScan® | 2023-08-09 A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamp |
| 10690286000770 - PROFILE®-IIA | 2023-06-09 A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamine, Cocaine, |
| 00690286000780 - PROFILE-II ER® | 2023-06-09 A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, |
| 00860001286533 - Men's Rapid Fertility Test | 2022-08-03 Men's Rapid Fertility Test, QC Kit |
| 00862105000398 - Trak | 2022-07-13 Trak Male Fertility Testing System, 1-Test Kit |
| 00862105000305 - Men's Rapid Fertility Test | 2022-06-21 Men's Rapid Fertility Test, 2-Test Kit |
| 00862105000312 - Men's Rapid Fertility Test | 2022-06-21 Men's Rapid Fertility Test, 2-Test Refill Kit |
Trademark Results [MEDTOXScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDTOXSCAN 78599342 3113146 Live/Registered |
LABORATORY CORPORATION OF AMERICA HOLDINGS 2005-03-31 |
 MEDTOXSCAN 78599338 3122100 Live/Registered |
LABORATORY CORPORATION OF AMERICA HOLDINGS 2005-03-31 |
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