EZ-SCREEN® CUP
GUDID 10690286000435
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 10690286000435 |
| NIH Device Record Key | 78685363-1a66-4949-b97d-d36419fbab28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZ-SCREEN® CUP |
| Version Model Number | 605102 |
| 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 | 00690286000438 [Primary] |
| GS1 | 10690286000435 [Package] Contains: 00690286000438 Package: Kit Box [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K002331
FDA Product Code
| DIS | Enzyme Immunoassay, Barbiturate |
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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