T-Cube ODOA-256EUO
GUDID 10816862022831
5-Panel T-Cube; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 10816862022831 |
| NIH Device Record Key | 3646d543-3442-46c2-b667-86447ee1aece |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-Cube |
| Version Model Number | ODOA-256EUO |
| Catalog Number | ODOA-256EUO |
| Company DUNS | 849098897 |
| Company Name | WONDFO USA CO., LTD. |
| Device Count | 25 |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.com | |
| Phone | 630-468-2199 |
| wondfo@wondfousa.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 |
| 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 | 00816862022834 [Primary] |
| GS1 | 00816862022841 [Unit of Use] |
| GS1 | 10816862022831 [Package] Contains: 00816862022834 Package: [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133968
FDA Product Code
| DKZ | Enzyme Immunoassay, Amphetamine |
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 | 2021-08-30 |
| Device Publish Date | 2021-08-20 |
On-Brand Devices [T-Cube]
| 10816862022060 | 6-Panel T-Cube; AMP,COC,MET,OPI,PCP,THC |
| 10816862022046 | 10-Panel T-Cube; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC |
| 00816862022001 | 6-Panel T-Cube; AMP,BAR,COC,OPI,PCP,THC |
| 00816862022377 | 6-Panel T-Cube; AMP,COC,MET,OPI,OXY,THC |
| 10816862022022 | 7-Panel T-Cube; AMP,COC,MET,OPI,OXY,PCP,THC |
| 10816862021995 | 5-Panel T-Cube; AMP,COC,MET,OPI,PCP |
| 10816862023210 | 10-Panel T-Cube for T-Reader; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC |
| 10816862022831 | 5-Panel T-Cube; AMP, COC, MET, OPI, THC |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.