Sienna Multi-Drug Test Cup
Sienna Multi-Drug Test Cup: 1 catalogue number listed by Advin Biotech, Inc., United States, under Enzyme Immunoassay, Amphetamine. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Advin Biotech, Inc., United States |
|---|---|
| FDA product code | DKZ |
| Device type | Enzyme Immunoassay, Amphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2022-10-20 |
| Record revised | 2025-08-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | 25 | In distribution |
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 |
|---|---|
| K122809 | 2013-06-17 |
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.