Rapid Response
10 Panel One Step DOA Cup (10.11) - COC(300) AMP(1000) MET(1000) THC(50) EDDP(300) MOP(300) OPI(2000) OXY(100) BZO(300) BUP(10)
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Btnx Inc., Canada |
|---|---|
| FDA product code | NGI |
| Device type | Test, Morphine, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3640 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K180349 |
| Record published | 2024-04-01 |
| Record revised | 2023-04-20 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| D10.1-1V | 25 | In distribution | |
| D5.1.1-1V | In distribution | ||
| D10.11-1V | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DrugTect Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2 |
| U-Catch Plus Multi-Drug Test Cup(Colloidal Gold) | Eterbio, 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.