SAFElife™
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 10 Test/Box
18manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (4), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| 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 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
Showing 12 of 18. All 18 manufacturers in China registered for Test, Opiates, Over The Counter
Record
| Listed by | Wondfo USA Co., Ltd., United States |
|---|---|
| FDA product code | NGL |
| Device type | Test, Opiates, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K241741 |
| Record published | 2024-12-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 30 °C |
| Packaging | Pack of 100, pack of 72, pack of 45, pack of 156, pack of 20, pack of 84 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DWFTY-OTC1-10BX | 10 | In distribution | |
| WFTY-OTC1-1BX | In distribution | ||
| DWDBU-114-10BX-A | 10 | In distribution | |
| WFTY-OTC1-10BX | 10 | In distribution | |
| WDFT-201-OTC1-10BX | 10 | In distribution | |
| WDFT-201-OTC1-25BX | 25 | In distribution | |
| DWFTY-OTC1-25BX | 25 | In distribution | |
| DWFTY-OTC1-10BX | 10 | In distribution | |
| WFTY-OTC1-5BX | 5 | In distribution | |
| WFTY-OTC1-25BX | 25 | In distribution | |
| DWFTY-OTC1-5BX | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Discover | American Screening, L.L.C. | 40 |
| Precision DX | American Screening, L.L.C. | 38 |
| Discover Plus | American Screening, L.L.C. | 22 |
| Precision Plus | American Screening, L.L.C. | 17 |
| OneScreen | American Screening, L.L.C. | 14 |
| Reveal | American Screening, L.L.C. | 11 |
| Rapid Response | Btnx Inc. | 8 |
| Identify Diagnostics Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 6 |
| Amazewell | Guangzhou Decheng Biotechnology Co., Ltd. | 5 |
| Alltest | Hangzhou AllTest Biotech Co., Ltd. | 5 |
| UScreen | Guangzhou Decheng Biotechnology Co., Ltd. | 5 |
| Clungene | Hangzhou Clongene Biotech Co., Ltd. | 4 |
Showing 12 of 90. All products under Test, Opiates, Over The Counter
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.