Amazewell
- Primary DI
- 30850054867507
- Brand
- Amazewell
- Company
- Guangzhou Decheng Biotechnology Co., LTD
- Model
- ASUD-2135
- Device description
- Amazewell™ Multi-Drug Urine Test Clicker Cup, 13-Panel, 25T/Box
- Published
- 2024-09-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| PTG | Test, Methadone, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K232659 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850054867506 | Primary | GS1 | 0 | |
| 30850054867507 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850054867506 | 00850054867506 | 850054867506 | 0850054867506 |
| 30850054867507 | 30850054867507 |
GMDN Terms#
| Term | Definition |
|---|---|
| Opiate/opiate metabolite IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of opiate and/or opiate metabolites in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 554534314
- Device count
- 25
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06974464591654 | One Step® LH Ovulation Rapid Test Dipstick (Urine) | 45T | 2026-07-15 | |
| 06974464591678 | One Step® LH Ovulation Rapid Test Dipstick (Urine) | 40T | 2026-07-22 | |
| 06974464591685 | One Step® LH Ovulation Rapid Test Dipstick (Urine) | 50T | 2026-07-22 | |
| 06974464591272 | One Step® Progesterone (PdG) Urine Test Strip | 6T | 2026-03-31 | |
| 06974464591296 | One Step® LH Ovulation Rapid Test Dipstick (Urine) | 20T | 2026-03-31 | |
| 06974464591302 | One Step® LH Ovulation Rapid Test Dipstick (Urine) | 30T | 2026-03-31 | |
| 06974464591319 | One Step® LH Ovulation Rapid Test Dipstick (Urine) | 60T | 2026-03-31 | |
| 00850081966005 | Pregmate | 50T | 2026-07-08 | |
| 06974464591333 | One Step® HCG Early Rapid Pregnancy Midstream Test | 5T | 2026-03-31 | |
| 06974464591340 | One Step® HCG Early Rapid Pregnancy Strips | 15T | 2026-03-31 | |
| 06974464591357 | One Step® 7-PANEL MULTI DRUG URINE TEST | 5T | 2026-03-31 | |
| 00075450847635 | Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test | IT415-3/V407 | 2026-02-20 | |
| 00075450847666 | Hy-Vee® Analog Pregnancy Rapid Test | IT000416-2/V407 | 2026-02-20 | |
| 00075450847673 | Hy-Vee® Digital Pregnancy Rapid Test | IT000417-2/V407 | 2026-02-20 | |
| 00075450847680 | Hy-Vee® Ovulation Kit | IT000418-11/V407 | 2026-02-20 | |
| 30075450847636 | Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test | IT415-3/V407 | 2026-02-20 | |
| 00075450847642 | Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test | IT415-2/V407 | 2026-02-20 | |
| 00075450847659 | Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test | IT415-1/V407 | 2026-02-20 | |
| 30075450847667 | Hy-Vee® Analog Pregnancy Rapid Test | IT000416-2/V407 | 2026-02-20 | |
| 30075450847674 | Hy-Vee® Digital Pregnancy Rapid Test | IT000417-2/V407 | 2026-02-20 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06937339211507 | BioSieve | Vivachek Biotech (Hangzhou) Co., Ltd. | PTG | 2026-10-14 |
| 06937339211538 | BioSieve | Vivachek Biotech (Hangzhou) Co., Ltd. | PTG | 2026-10-14 |
| 06974541566049 | BioTeke | Bioteke Corporation (Wuxi) Co., Ltd. | PTG | 2026-10-13 |
| 06942598249413 | One Step® Methadone (MTD300) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-10-12 |
| 10722066005511 | Rapid Response | BTNX Inc | PTG | 2026-10-09 |
| 10722066018979 | Rapid Response | BTNX Inc | PTG | 2026-10-08 |
| 10722066019013 | Rapid Response | BTNX Inc | PTG | 2026-10-08 |
| 10722066019020 | Rapid Response | BTNX Inc | PTG | 2026-10-08 |
| 10722066019037 | Rapid Response | BTNX Inc | PTG | 2026-10-08 |
| 10722066019044 | Rapid Response | BTNX Inc | PTG | 2026-10-08 |
| 10722066018955 | Rapid Response | BTNX Inc | PTG | 2026-10-06 |
| 10722066018696 | Rapid Response | BTNX Inc | PTG | 2026-09-18 |
| 06936983113960 | Alltest MTD300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114073 | Alltest EDDP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114110 | Alltest MTD300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114233 | Alltest MTD300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114288 | Alltest EDDP300 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114356 | Alltest EDDP300 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114387 | Alltest MTD300 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114479 | Alltest EDDP300 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114530 | Alltest MTD300 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114622 | Alltest EDDP300 Home Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983113922 | Alltest EDDP300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-17 |
| 16936983131633 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983131640 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983138632 | Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983141120 | Discover Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983141137 | Discover Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 16936983144688 | Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |
| 06936983114790 | Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-16 |