Healgen
12 Panel DOA Test clear Round Cup With Clicker;+ Adulterant Test StripsOXI/SG/pH
16manufacturers in China registered for this device type
69catalogue numbers in this listing
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 | Healgen Scientific Limited Liability Company |
|---|---|
| FDA product code | DKZ |
| Device type | Enzyme Immunoassay, Amphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Record published | 2017-05-08 |
| Record revised | 2022-06-10 (version 5) |
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 |
| Storage | Handling environment temperature 2 to 30 °C |
| Packaging | Inner pack of 25, case of 4, case of 20, case of 100, inner pack of 100 |
| Distribution end date | 2020-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HCDOAV-454 | In distribution | |
| HCDOAV-4124A3 | In distribution | |
| DOAY-6124 | In distribution | |
| HCDOAV-474 | In distribution | |
| HCDOAV-874 | In distribution | |
| HCDOAV-6125S | In distribution | |
| DOAY-3104 | In distribution | |
| HCDOAV-1104SA3 | In distribution | |
| DOAY-2135A3 | In distribution | |
| HDBZ-114 | In distribution | |
| HCDOAV-6124 | In distribution | |
| HCDOAV-3125 | In distribution | |
| HDOA-285 | In distribution | |
| HCDOAEW-2135 | In distribution | |
| GBOPI-101a | In distribution | |
| HDOX-114 | In distribution | |
| HDOP-101 | In distribution | |
| HDOA-565 | In distribution | |
| HDMA-114 | In distribution | |
| HCDOAV-2135 | In distribution | |
| HCDOAV-955 | In distribution | |
| HDTH-114 | In distribution | |
| HCDOAV-4104A3 | In distribution | |
| HCDOAV-975 | In distribution | |
| DOAY-1144A3 | In distribution | |
| HCDOAEC-6125S | In distribution | |
| HCDOAEW-955 | In distribution | |
| HCDOAEC-6125 | In distribution | |
| HCDOAV-154A3 | In distribution | |
| HDBA-114 | In distribution | |
| HCDOAEW-2135A3 | In distribution | |
| HCDOA-6124A3 | In distribution | |
| HDOP-114 | In distribution | |
| HCDOAV-154 | In distribution | |
| HDOA-585T | In distribution | |
| HCDOAV-10115 | In distribution | |
| HCDOAV-285TS | In distribution | |
| HCDOAV-7105 | In distribution | |
| HDOA-124 | In distribution | |
| HDMO-114 | In distribution | |
| HDBU-201 | In distribution | |
| HCDOA-154 | In distribution | |
| DOAY-4104 | In distribution | |
| HCDOAV-7104A3 | In distribution | |
| DOAY-8104 | In distribution | |
| HCDOAEW-8105A3A | In distribution | |
| HCDOAV-8105 | In distribution | |
| HCDOAV-4105S | In distribution | |
| HCDOAV-9125T | In distribution | |
| HCDOAV-8104 | In distribution | |
| HCDOAV-3124A3 | In distribution | |
| HCDOAEW-6124 | In distribution | |
| HDOA-675H | In distribution | |
| HCDOA-1174 | In distribution | |
| HCDOAEW-6125A3 | In distribution | |
| HDOA-664 | In distribution | |
| HCDOAV-8105A3 | In distribution | |
| HCDOA-1104SA3 | In distribution | |
| HDAM-114 | In distribution | |
| HCDOAV-785 | In distribution | |
| HCDOAV-4124 | In distribution | |
| DOAY-6124A3 | In distribution | |
| HDCO-201 | In distribution | |
| HCDOA-254A3 | In distribution | |
| HCDOAV-145S | In distribution | |
| DOAY-564 | In distribution | |
| HDOA-4104A3 | In distribution | |
| HDTH-201 | In distribution | |
| HCDOAV-955 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| UCP Home Drug Screening Test Cups | UCP Biosciences, Inc. | 9 |
Showing 12 of 223. All products under Enzyme Immunoassay, Amphetamine
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.