Co-Innovation
Rapid Multi-drug Test Cup
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (7), Guangdong (3), Beijing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 21 |
Showing 12 of 13. All 13 manufacturers in China registered for Enzyme Immunoassay, Benzodiazepine
Record
| Listed by | Co-Innovation Biotech Co., Ltd., China |
|---|---|
| FDA product code | JXM |
| Device type | Enzyme Immunoassay, Benzodiazepine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3170 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K153050 |
| Record published | 2022-11-11 |
| Record revised | 2022-12-20 (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 |
| Packaging | Pack of 25, pack of 100, pack of 210 |
| Distribution end date | 2022-11-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Rapid Multi-drug Test | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MD DugScreen | Medical Disposables Corp | 27 |
| First Sign® | Hemosure Inc. | 26 |
| MD DrugScreen | Medical Disposables Corp | 20 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 17 |
| Statdip® | Micro Distributing, L.C | 17 |
| Statcup® II | Micro Distributing, L.C | 16 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 15 |
| Healgen | Healgen Scientific Limited Liability Company | 13 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 11 |
| ECO™ Cup | W.h.p.m., Inc. | 8 |
| ECO™ II Cup | W.h.p.m., Inc. | 8 |
| U-Screen | Instant Tech Subsidiary Acquisition | 7 |
Showing 12 of 145. All products under Enzyme Immunoassay, Benzodiazepine
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.