T-Cup®
GUDID 00817405021086
T-Cup® Multi-Drug Urine Test Cup with Adulterants (CR, NI, pH, OX, SG) 7 panel AMP1000, COC300, MET500, OPI300, OXY100, PCP25, THC50
Instant Technologies, Inc.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00817405021086 |
| NIH Device Record Key | 717778d6-f167-45c7-95d0-13b01b3cbb75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-Cup® |
| Version Model Number | TDOA-7A |
| Company DUNS | 019410187 |
| Company Name | Instant Technologies, 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 | 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 | |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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| Phone | 1-800-340-4029 |
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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 |
| 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 |
| 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 | 00817405021086 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182701
FDA Product Code
| NGM | Test, Phencyclidine (Pcp), Over The Counter |
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 | 2019-10-31 |
| Device Publish Date | 2019-10-23 |
Devices Manufactured by Instant Technologies, Inc.
| 30817405024118 - iScreen™ | 2024-08-14 iScreen 10 Panel CLIA Click Cup AMP1000, BAR300, BZO300, COC300, MET1000, MDMA500, MOP300, MTD300, OXY100, THC50 |
| 10817405024077 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-07-24 iScreen 9 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MDMA/MTD)+(BZO/BAR)+(MET/OPI/PCP) |
| 10817405024084 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-07-24 iScreen 10 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(AMP/COC)+(MET/MOP/PCP)+(BZO/MTD/BAR) |
| 10817405024107 - iScreen™ Urine Test E-Z Split Key™ Drug Screen Cup | 2024-07-24 iScreen 8 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+++(MET/OPI/PCP)+(BZO/MTD/BAR) |
| 30817405024033 - iScreen™ | 2024-01-05 9 Panel Privacy EUO Oral Fluid COC20, OPI40, MDMA50, OXY20, THC40, 6AM/HRN10, MET50, AMP50, PCP10 |
| 30817405024040 - iScreen™ | 2024-01-05 11 Panel Privacy EUO Oral Fluid BUP5, AMP50, MDMA50, COC20, OXY20, BAR50, OPI40, BZO10, MET50, MTD30, THC40 |
| 30817405024057 - iScreen™ | 2023-12-15 5 Panel Privacy EUO Oral Fluid MET50, OXY20, OPI40, AMP50, COC20 |
| 30817405024064 - iScreen™ | 2023-12-15 6 Panel Masked EUO Oral Fluid AMP50, THC40, OXY20, COC20, MET50, OPI40 |
Trademark Results [T-Cup]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-CUP 87151774 5212506 Live/Registered |
Wondfo USA Co., Ltd. 2016-08-26 |
 T-CUP 86362305 not registered Dead/Abandoned |
Minnesota Medtech 2014-08-10 |
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