PROFILE-II ER®
GUDID 00690286000315
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00690286000315 |
| NIH Device Record Key | 8747b0a8-0785-4259-b614-8f6a274ebcac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROFILE-II ER® |
| Version Model Number | 601674 |
| 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 | 00690286000315 [Primary] |
| GS1 | 10690286000312 [Package] Package: kit box [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K002331
FDA Product Code
| JXN | Enzyme Immunoassay, Propoxyphene |
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 [PROFILE-II ER®]
| 00690286000315 | A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), |
| 10690286000299 | A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), |
| 10690286000282 | A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), |
| 10690286000275 | A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), |
| 00690286000780 | A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), |
Trademark Results [PROFILE-II ER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFILE-II ER 78231820 2815137 Live/Registered |
LABORATORY CORPORATION OF AMERICA HOLDINGS 2003-03-31 |
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