T-Dip
GUDID 10816862024286
1-Panel Card; AMP Amphetamine 500 ng/ml
WONDFO USA CO., LTD.
Multiple drugs of abuse IVD, kit, rapid ICT, clinical| Primary Device ID | 10816862024286 |
| NIH Device Record Key | 18bfd2d5-54e8-4ef3-acc7-c1101b52fa2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T-Dip |
| Version Model Number | WAMP-500-CLIA-M |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816862024289 [Primary] |
| GS1 | 00816862024296 [Unit of Use] |
| GS1 | 10816862024286 [Package] Contains: 00816862024289 Package: [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050024
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 | 2024-05-27 |
| Device Publish Date | 2024-05-17 |
On-Brand Devices [T-Dip]
| 10816862023654 | 6-Panel Card without THC; BUP,BZO,COC,MOP,MTD,OXY |
| 10816862023036 | 3-Panel Card;COC300,OPI2000,THC50 |
| 10816862024286 | 1-Panel Card; AMP Amphetamine 500 ng/ml |
Trademark Results [T-Dip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T-DIP 87732992 5619008 Live/Registered |
Wondfo USA Co., Ltd. 2017-12-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.