Cedia Amphetamines/Ecstasy Assay
2 catalogue numbers from 100104, listed by Microgenics Corporation, United States, under Gas Chromatography, Methamphetamine. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Microgenics Corporation, United States |
|---|---|
| FDA product code | LAF |
| Device type | Gas Chromatography, Methamphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3610 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K010496 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100104 | In distribution | |
| 100103 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101753 | 2011-04-08 |
| K010496 | 2001-05-29 |
| K904413 | 1990-11-05 |
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.