Amazewell
GUDID 30850065976502
Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
Tricyclic antidepressant IVD, kit, rapid ICT, clinical| Primary Device ID | 30850065976502 |
| NIH Device Record Key | 5e2c4f5a-0361-45e3-a37a-9c2c7f90328b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amazewell |
| Version Model Number | AFD-6124 |
| Company DUNS | 554534314 |
| Company Name | Guangzhou Decheng Biotechnology 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 | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850065976501 [Primary] |
| GS1 | 30850065976502 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240698
FDA Product Code
| NFV | Test, Benzodiazepine, 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 | 2024-10-07 |
| Device Publish Date | 2024-09-27 |
On-Brand Devices [Amazewell]
| 30850054867194 | Amazewell™ Lollipop Oral Fluid Drug Test, 5-Panel, 25T/Box |
| 30850054867187 | Amazewell™ Lollipop Oral Fluid Drug Test, 6-Panel, 25T/Box |
| 30850054867170 | Amazewell™ Lollipop Oral Fluid Drug Test, 4-Panel, 25T/Box |
| 30850054867163 | Amazewell™ Lollipop Oral Fluid Drug Test, 5-Panel, 25T/Box |
| 30850054867149 | Amazewell™ Lollipop Oral Fluid Drug Test, 10-Panel, 25T/Box |
| 30850054867095 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 6-Panel , 25T/Box |
| 30850054867088 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 5-Panel, 25T/Box |
| 30850054867071 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 9-Panel, 25T/Box |
| 30850054867064 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box |
| 30850054867057 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 11-Panel, 25T/Box |
| 30850054867040 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 10-Panel, 25T/Box |
| 30850054867033 | Amazewell™ D-Pen™ Mini THC Oral Fluid Test, 10T/Box |
| 30850054867026 | Amazewell™ D-Pen™ Mini COT Oral Fluid Test, 10T/Box |
| 30850054867019 | Amazewell Ovulation and Pregnancy Combo Test Kit, Strip, 50 LH + 20 HCG, 70T/Box |
| 30850054867002 | Amazewell Ovulation and Pregnancy Combo Test Kit, Strip, 10 LH + 2 HCG, 12T/Bag |
| 30850065976519 | Amazewell™ Multi-Drug Urine Test Dipcard, 10-Panel, 25T/Box |
| 30850065976502 | Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box |
| 30850065976496 | Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box |
| 30850065976489 | Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box |
| 30850065976472 | Amazewell™ Multi-Drug Urine Test Dipcard, 6-Panel, 25T/Box |
| 30850065976465 | Amazewell™ Multi-Drug Urine Test Dipcard, 5-Panel, 25T/Box |
| 30850065976458 | Amazewell™ Multi-Drug Urine Test Dipcard, 5-Panel, 25T/Box |
| 30850054867989 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 5-Panel, 25T/Box |
| 30850054867965 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 10-Panel, 25T/Box |
| 30850054867897 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 9-Panel, 25T/Box |
| 00850054867841 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 13-Panel |
| 00850054867803 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 7-Panel |
| 00850054867797 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 6-Panel |
| 00850054867773 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 9-Panel |
| 30850054867453 | Amazewell™ Ovulation Rapid Test Midstream, 20T/Box |
| 30850054867446 | Amazewell™ Digital Ovulation Test Kit, 10T/Box |
| 30850054867439 | Amazewell™ Pregnancy Rapid Test Strip, 5T/Bag |
| 30850054867422 | Amazewell™ Pregnancy Rapid Test Strip, 25T/Box |
| 30850054867415 | Amazewell™ Pregnancy Rapid Test Midstream, 2T/Box |
| 00850054867407 | Amazewell™ Pregnancy Rapid Test Midstream, 1T/Box |
| 30850054867392 | Amazewell™ Digital Pregnancy Rapid Test, 5T/Box |
| 00850054867384 | Amazewell™ Digital Pregnancy Rapid Test, 1T/Box |
| 30850054867316 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 10-Panel, 25T/Box |
| 30850054867286 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box |
| 30850054867279 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box |
| 30850054867262 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 6-Panel, 25T/Box |
| 30850054867255 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 12-Panel, 25T/Box |
| 30850054867248 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 5-Panel, 25T/Box |
| 30850054867231 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 13-Panel, 25T/Box |
| 30850054867224 | Amazewell™ Multi-Drug Urine Test Clicker Cup, 14-Panel, 25T/Box |
| 30850054867132 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 5-Panel, 25T/Box |
| 30850054867118 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 4-Panel , 25T/Box |
| 30850054867101 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 7-Panel , 25T/Box |
| 00850054867735 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 8-Panel |
| 00850054867728 | Amazewell™ D-Pen™ Oral Fluid Drug Test, 7-Panel |
Trademark Results [Amazewell]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMAZEWELL 97929758 not registered Live/Pending |
DOCHEK USA INC. 2023-05-10 |
 AMAZEWELL 97929739 not registered Live/Pending |
DOCHEK USA INC. 2023-05-10 |
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