DrugSmart Dip 7
7-Panel DrugSmart Dip, AMP500/COC150/THC50/BAR200/BZO200/MDMA500/MOR
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 | Chemtron Biotech, Inc., United States |
|---|---|
| FDA product code | DNK |
| Device type | Thin Layer Chromatography, Morphine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3640 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K142396 |
| Record published | 2019-01-31 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30735D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Generic | Chemtron Biotech, Inc. | 2 |
| Premier Biotech | Chemtron Biotech, Inc. | 2 |
| Rapid Response | Btnx Inc. | 1 |
| Leader | Cardinal Health 110, 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.