U-Catch Plus Multi-Drug Test Cup(Colloidal Gold)
1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
4manufacturers in China registered for this device type
1catalogue number
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 | Eterbio, Inc., China |
|---|---|
| FDA product code | NGI |
| Device type | Test, Morphine, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3640 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K182530 |
| Record published | 2024-12-17 |
| Record revised | 2025-02-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETG004001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rapid Response | Btnx Inc. | 3 |
| DrugTect Multi-Drug Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2 |
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.