Benzodiazepine Intercept 5 Plate Kit
Catalogue number 1110IB, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Benzodiazepine. 13 manufacturers in China are registered for 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 | Orasure Technologies, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2026-05-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2025-04-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1110IB | Withdrawn |
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 |
|---|---|
| K013882 | 2002-04-17 |
| K982831 | 1998-11-12 |
Recalls
2 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-07-13 | Class III | Under Investigation by firm | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box | 39 kits | 2021-06-08 |
| 2020-07-13 | Class III | Under Investigation by firm | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box | 13 kits | 2021-06-08 |
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.