Mlife Classic
6 Panel Oral Fluid Drug Test
11manufacturers in China registered for this device type
1catalogue number
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 | Mlife Diagnostics LLC, United States |
|---|---|
| FDA product code | PUX |
| Device type | Test, Amphetamine, Employment And Insurance Testing, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-04-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
| Packaging | Box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M310601-EI | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iSCREEN™ | Instant Technologies, Inc. | 17 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 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 |
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.