EZ-SCREEN® CUP
GUDID 10690286000411
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 10690286000411 |
| NIH Device Record Key | d042ca78-2da2-472b-b852-ac9e0efa8577 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZ-SCREEN® CUP |
| Version Model Number | 605100 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690286000414 [Primary] |
| GS1 | 10690286000411 [Package] Contains: 00690286000414 Package: Kit Box [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K010226
FDA Product Code
| DJG | Enzyme Immunoassay, Opiates |
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 | 2016-09-16 |
On-Brand Devices [EZ-SCREEN® CUP]
| 00690286000537 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000520 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000513 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000506 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000490 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000483 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000476 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000469 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 00690286000452 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 10690286000442 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 10690286000435 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 10690286000428 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 10690286000411 | A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), |
| 10690286000701 | A qualitative one-step immunochromatographic test panel for the detection of Opiates, Methamphet |
| 10690286000695 | A qualitative one-step immunochromatographic test panel for the detection of Opiates, Cocaine, P |
Trademark Results [EZ-SCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZ-SCREEN 77015560 3606403 Dead/Cancelled |
Phylonix Pharmaceuticals, Inc. 2006-10-06 |
 EZ-SCREEN 76312126 2896092 Live/Registered |
Banner Engineering Corporation 2001-09-17 |
 EZ-SCREEN 76162257 not registered Dead/Abandoned |
UB-Port, Inc 2000-11-02 |
 EZ-SCREEN 73553126 1412788 Live/Registered |
ENVIRONMENTAL DIAGNOSTICS INC. 1985-08-12 |
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