T-Cube® Tcube-7PCP
GUDID 00858945006997
T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following drugs of abuse and their principal metabolites in human oral fluid at specified cut-off levels for use in employment and insurance testing: AMP, COC, MET, OPI, OXY, PCP, THC.
Instant Technologies, Inc.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00858945006997 |
| NIH Device Record Key | 71163370-4cf0-43ef-b7dd-0301d31c12a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-Cube® |
| Version Model Number | Tcube-7PCP |
| Catalog Number | Tcube-7PCP |
| Company DUNS | 019410187 |
| Company Name | Instant Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-340-4029 |
| qa.portsmouth@alere.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com | |
| Phone | 1-800-340-4029 |
| Qa.Portsmouth@abbott.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858945006997 [Primary] |
FDA Product Code
| PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2019-01-31 |
On-Brand Devices [T-Cube® ]
| 00858945006997 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00858945006928 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00858945006911 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00858945006904 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00858945006898 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the followin |
| 00858945006881 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00858945006874 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020997 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020980 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020966 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020959 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020942 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020935 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020928 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020577 | T-Cube® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405020393 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
| 00817405021284 | T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following |
Trademark Results [T-Cube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-CUBE 88095367 not registered Dead/Abandoned |
Thorlabs, Inc. 2018-08-28 |
 T-CUBE 87361540 5342703 Live/Registered |
Wondfo USA Co., Ltd. 2017-03-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.