Co-Innovation
14P Drug Test
16manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| 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 |
| Assure Tech. (Hangzhou) 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 |
Showing 12 of 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Amphetamine
Record
| Listed by | Co-Innovation Biotech Co., Ltd., China |
|---|---|
| FDA product code | DKZ |
| Device type | Enzyme Immunoassay, Amphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K153050 |
| Record published | 2022-01-15 |
| Record revised | 2022-12-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25, pack of 100, pack of 210 |
| Distribution end date | 2022-01-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14P Drug Test | Withdrawn | |
| 17P Drug Test | Withdrawn | |
| 18P Drug Test | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 69 |
| First Sign® | Hemosure Inc. | 39 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 38 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 21 |
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 17 |
| T-Square | Wondfo USA Co., Ltd. | 15 |
| Enzyme Immunoassay, Amphetamine | W.h.p.m., Inc. | 15 |
| Statcup® II | Micro Distributing, L.C | 12 |
| MD DugScreen | Medical Disposables Corp | 12 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 11 |
| Noble Drug Test Cup (Urine) | Noble Medical Inc | 10 |
| ECO II Cup ® | W.h.p.m., Inc. | 10 |
Showing 12 of 223. All products under Enzyme Immunoassay, Amphetamine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142800 | 2014-12-11 |
| K131110 | 2014-01-15 |
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.