Icup™
MDML Screen Test Card with the Integrated iCup with AD Strips
10manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (2), Beijing (1). 2 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 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| 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 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Hongkong Conlight Medical Group Limited | Tai Kok Tsui | Hong Kong | Specification developer | 11 |
| Nantong Egens Biotechnology Co., Ltd. | Nantong | Jiangsu | Manufacturer | 7 |
Record
| Listed by | Instant Technologies, Inc. |
|---|---|
| FDA product code | LAF |
| Device type | Gas Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| Record published | 2023-02-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DUD-1107-012 | 25 | In distribution | |
| DUE-187-071 | 25 | In distribution | |
| DUE-1107-141 | 25 | In distribution | |
| DUA-197-013 | 25 | In distribution | |
| DUA-187-013 | 25 | In distribution | |
| DOA-1107-011 | 25 | In distribution | |
| DUA-187-012 | 25 | In distribution | |
| DUA-167-022 | 25 | In distribution | |
| DUA-157-115 | 25 | In distribution | |
| DUD-197-014 | 25 | In distribution | |
| DUE-1127-022 | 25 | In distribution | |
| DUA-147-012 | 25 | In distribution | |
| DUE-147-241 | 25 | In distribution | |
| DOA-1107-051 | 25 | In distribution | |
| DOA-1117-111 | 25 | In distribution | |
| DUA-167-012 | 25 | In distribution | |
| DUA-157-034 | 25 | In distribution | |
| DUA-167-291 | 25 | In distribution | |
| DOA-197-041 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iScreen™ | Instant Technologies, Inc. | 52 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 27 |
| Gas Chromatography, Methamphetamine | W.h.p.m., Inc. | 25 |
| MD DugScreen | Medical Disposables Corp | 18 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 9 |
| Healgen | Healgen Scientific Limited Liability Company | 8 |
| Statdip® | Micro Distributing, L.C | 8 |
| ProScreen | Instant Tech Subsidiary Acquisition | 6 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 5 |
| First Sign® | Hemosure Inc. | 5 |
| Generic | Chemtron Biotech, Inc. | 5 |
| Wondfo Drug Test Dip Card | Wondfo USA Co., Ltd. | 4 |
Showing 12 of 76. All products under Gas Chromatography, Methamphetamine
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.