Drug Test Dip Card
Drug Test Dip Card (AMP1000, BAR300, BZO300, COC300, mAMP1000, MOP300, MTD300, OXY100, PCP25, THC50)
10manufacturers in China registered for this device type
1catalogue number
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 |
| 510(k) | K133968 |
| Record published | 2020-03-10 |
| Record revised | 2024-10-14 (version 7) |
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 | Storage environment temperature 4 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AWDOA-114 | 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 |
| 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 |
Showing 12 of 76. All products under Gas Chromatography, Methamphetamine
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. |
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.