Rapid Response
Rapid Response Single Drug Test Cassette (MOP) - 40 tests/ kit are for the qualitative detection of morphine in urine.
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 | Btnx Inc., Canada |
|---|---|
| FDA product code | DNK |
| Device type | Thin Layer Chromatography, Morphine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3640 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K121065 |
| Record published | 2019-10-16 |
| Record revised | 2023-04-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MOP-1C3-40 | 40 | 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 |
| 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.