Gas Chromatography, Methamphetamine
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC
10manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
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 | W.h.p.m., Inc., United States |
|---|---|
| FDA product code | LAF |
| Device type | Gas Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-08-01 |
| 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 |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| W254 | 25 | In distribution | |
| WMA-Strip | 100 | In distribution | |
| CW4104 | 25 | In distribution | |
| W194 | 25 | In distribution | |
| CW12104 | 25 | In distribution | |
| WMA-25 | 25 | In distribution | |
| WMA500-25 | 25 | In distribution | |
| WMD-25 | 25 | In distribution | |
| W254RD | 25 | In distribution | |
| W144 | 25 | In distribution | |
| W174 | 25 | In distribution | |
| W254 W/AD | 25 | In distribution | |
| W384 | 25 | In distribution | |
| W454 | 25 | In distribution | |
| W2104 | 25 | In distribution | |
| W174 W/AD | 25 | In distribution | |
| W184 | 25 | In distribution | |
| W264RD | 25 | In distribution | |
| W1104 | 25 | In distribution | |
| W1144 | 25 | In distribution | |
| W354 | 25 | In distribution | |
| WMD-Strip | 100 | In distribution | |
| W4104 | 25 | In distribution | |
| CW1104 | 25 | In distribution | |
| W1104RD | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| iScreen™ | Instant Technologies, Inc. | 52 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 27 |
| iCup™ | Instant Technologies, Inc. | 19 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150162 | 2015-02-26 |
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.