First Sign®
DOA 14 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC/PH-SG-OX
16manufacturers in China registered for this device type
39catalogue 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 | Hemosure Inc. |
|---|---|
| FDA product code | DKZ |
| Device type | Enzyme Immunoassay, Amphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Record published | 2016-09-06 |
| Record revised | 2022-06-10 (version 4) |
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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FSCECOII-1984 | 25 | In distribution | |
| FSCWAM-25 | 25 | In distribution | |
| FSCCUP-264 W/AD2 | 25 | In distribution | |
| FSCECOII-174 | 25 | In distribution | |
| FSCECOII-3464 | 25 | In distribution | |
| FSCCUP-4254 | 25 | In distribution | |
| FSCCUP-874 | 25 | In distribution | |
| FSCDIP4854 | 25 | In distribution | |
| FSCCUP-06144 W/AD | 25 | In distribution | |
| FSCDIP264 | 25 | In distribution | |
| FSCDIP3464 | 25 | In distribution | |
| FSCCUP-47104 W/AD | 25 | In distribution | |
| FSCCUP-06144 W/AD2 | 25 | In distribution | |
| FSCDIP11024 | 25 | In distribution | |
| FSCCUP-47104 W/AD2 | 25 | In distribution | |
| FSCW1024 | 25 | In distribution | |
| FSCDIPAM-25 | 25 | In distribution | |
| FSCDIP334 | 25 | In distribution | |
| FSCDIP5964 | 25 | In distribution | |
| FSCCUP-5764 | 25 | In distribution | |
| FSCCUP-4854 | 25 | In distribution | |
| FSCDIP13124 | 25 | In distribution | |
| FSCDIP174 | 25 | In distribution | |
| FSCCUP-06144 | 25 | In distribution | |
| FSCCUP-9124 W/AD2 | 25 | In distribution | |
| FSCCUP-04144 | 25 | In distribution | |
| FSCCUP-09134 | 25 | In distribution | |
| FSCDIP3104 | 25 | In distribution | |
| FSCCUP-21124 | 25 | In distribution | |
| FSCDIP2974 | 25 | In distribution | |
| FSCW4254 | 25 | In distribution | |
| FSCW874 | 25 | In distribution | |
| FSCCUP-9124 W/AD | 25 | In distribution | |
| FSCECOII-154 | 25 | In distribution | |
| FSCCUP-04144 W/AD2 | 25 | In distribution | |
| FSCECOII-264 | 25 | In distribution | |
| FSCECOII-2974 | 25 | In distribution | |
| FSCCUP-47104 | 25 | In distribution | |
| FSCDIP154 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 69 |
| 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.