Benz
The Benzodiazepine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Benzodiazepines in human urine
13manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (7), 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 |
|---|---|---|---|---|
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| 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 |
| 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 |
| 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 |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 21 |
Showing 12 of 13. All 13 manufacturers in China registered for Enzyme Immunoassay, Benzodiazepine
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | JXM |
| Device type | Enzyme Immunoassay, Benzodiazepine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K092274 |
| Record published | 2016-09-24 |
| Record revised | 2020-12-21 (version 3) |
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 8 °C; Special storage condition: Once opened the reagent is stable on board the analyser for 28 days at approximately +10°C. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DA4009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MD DugScreen | Medical Disposables Corp | 27 |
| First Sign® | Hemosure Inc. | 26 |
| MD DrugScreen | Medical Disposables Corp | 20 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 17 |
| Statdip® | Micro Distributing, L.C | 17 |
| Statcup® II | Micro Distributing, L.C | 16 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 15 |
| Healgen | Healgen Scientific Limited Liability Company | 13 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 11 |
| ECO™ Cup | W.h.p.m., Inc. | 8 |
| ECO™ II Cup | W.h.p.m., Inc. | 8 |
| U-Screen | Instant Tech Subsidiary Acquisition | 7 |
Showing 12 of 145. All products under Enzyme Immunoassay, Benzodiazepine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092274 | 2010-10-15 |
| K050179 | 2005-05-17 |
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.