Panel Dip
Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Barbiturate. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (3), Beijing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| 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 |
| Hongkong Conlight Medical Group Limited | Tai Kok Tsui | Hong Kong | Specification developer | 11 |
Record
| Listed by | Assure Tech. (Hangzhou) Co., Ltd., China |
|---|---|
| FDA product code | DIS |
| Device type | Enzyme Immunoassay, Barbiturate |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3150 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K151211 |
| Record published | 2016-09-19 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MD DugScreen | Medical Disposables Corp | 9 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 7 |
| Healgen | Healgen Scientific Limited Liability Company | 6 |
| ProScreen | Instant Tech Subsidiary Acquisition | 5 |
| EZ-Screen® CUP | Medtox Diagnostics, Inc. | 5 |
| Immunalysis | Immunalysis Corporation | 4 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 4 |
| MD DrugScreen | Medical Disposables Corp | 4 |
| QuickTox Drug Screen Dipcard | Ameditech, Inc. | 4 |
| TOX/See | Bio-Rad Laboratories Inc. | 3 |
| DRI Barbiturate Assay | Microgenics Corporation | 3 |
| QuickTox Drug Screen Dipcard | Branan Medical Corporation | 3 |
Showing 12 of 102. All products under Enzyme Immunoassay, Barbiturate
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.