Leader
LDR At-Home Drug Test (5 drugs tested)
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Nantong Egens Biotechnology Co., Ltd. | Nantong | Jiangsu | Manufacturer | 7 |
Record
| Listed by | Cardinal Health 110, Inc. |
|---|---|
| FDA product code | DNK |
| Device type | Thin Layer Chromatography, Morphine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3640 |
| Record published | 2021-06-11 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5688320 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Generic | Chemtron Biotech, Inc. | 2 |
| Premier Biotech | Chemtron Biotech, Inc. | 2 |
| DrugSmart Dip 7 | Chemtron Biotech, Inc. | 1 |
| Rapid Response | Btnx Inc. | 1 |
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.