Amazewell
Amazewell Lollipop Oral Fluid Drug Test is a single-use oral-fluid test in a six-panel configuration. The lollipop format identifies the sample-collection style, while the listed kit is…
Amazewell Lollipop Oral Fluid Drug Test is a single-use oral-fluid test in a six-panel configuration. The lollipop format identifies the sample-collection style, while the listed kit is packaged as a 25-test box.
The lollipop form identifies the sample collection and test format, with the filed six-panel configuration packaged as 25 tests.
Listed Item
Amazewell™ Lollipop Oral Fluid Drug Test, 6-Panel, 25T/Box
Product Format
The LTO-166EUO is packaged as a 25-test box of single-use oral-fluid screening tests. Its lollipop form identifies the collection and test format, while the six-panel designation marks the configured screening panel.
The test is an in vitro device for screening oral-fluid samples. The supplied instructions define the panel targets and how results are read for this exact model.
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (3), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Hangzhou Tongzhou Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 14 |
| Xiamen Boson Biotech Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
Record
| Listed by | Guangzhou Decheng Biotechnology Co., Ltd., China |
|---|---|
| FDA product code | PUX |
| Device type | Test, Amphetamine, Employment And Insurance Testing, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-09-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DPO-154EUO | 25 | In distribution | |
| DPO-276EUO | In distribution | ||
| LTO-166EUO | 25 | In distribution | |
| DPO-266EUO | In distribution | ||
| LTO-256EUO | 25 | In distribution | |
| LTO-154EUO | 25 | In distribution | |
| DPO-166EUO | 25 | In distribution | |
| DPO-396FPA | 25 | In distribution | |
| DPO-496NTEUO | In distribution | ||
| LTO-744EUO | 25 | In distribution | |
| DPO-256EUO | 25 | In distribution | |
| DPO-276 | In distribution | ||
| LTO-156EUO | In distribution | ||
| DPO-186 | In distribution | ||
| DPO-10106EUO | 25 | In distribution | |
| DPO-1116PA | 25 | In distribution | |
| DPO-276 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iSCREEN™ | Instant Technologies, Inc. | 17 |
| Prime Screen | Wondfo USA Co., Ltd. | 10 |
| Classic | Mlife Diagnostics LLC | 9 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 7 |
| Verify | Mlife Diagnostics LLC | 5 |
| Noble Dip Card with AD (Urine) | Noble Medical Inc | 4 |
| UScreen Oral | Guangzhou Decheng Biotechnology Co., Ltd. | 3 |
| T-Cube® | Instant Technologies, Inc. | 3 |
| Statswab® | Micro Distributing, L.C | 3 |
| Rapid Response 6 Panel Saliva Test Cup E/I Screening | Btnx Inc. | 3 |
| Origin Instant Oral Drug Test | Origin Diagnostics LLC | 2 |
| mLife Verify | Mlife Diagnostics LLC | 2 |
Showing 12 of 28. All products under Test, Amphetamine, Employment And Insurance Testing, Exempt
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.