Classic
mLife Classic 11 panel oral fluid drug test AMP-BAR-BZO-COC-FYL-MDMA-MET-OPI-OXY-PCP-THC
11manufacturers in China registered for this device type
9catalogue numbers in this listing
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 | 2023-07-15 |
| Record revised | 2026-04-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 30 °C |
| Distribution end date | 2026-04-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M310601 | In distribution | |
| MC001.10.0001-EI | Withdrawn | |
| MC001.05.0001-EI | Withdrawn | |
| MC002.10.0001EI | Withdrawn | |
| M310501 | Withdrawn | |
| MC002.08.0001EI | Withdrawn | |
| MC001.05.0002EI | Withdrawn | |
| MC001.06.0001-EI | Withdrawn | |
| MC002.11.0001EI | Withdrawn |
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 |
| 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.