Emit II Plus Oxycodone Assay 30 Ml Kit
Catalogue number 10720808, listed by Siemens Healthcare Diagnostics Inc, United States, under Enzyme Immunoassay, Opiates. 17 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (4), Beijing (2). 5 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 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| 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 |
Showing 12 of 17. All 17 manufacturers in China registered for Enzyme Immunoassay, Opiates
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | DJG |
| Device type | Enzyme Immunoassay, Opiates |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172910 |
| Record published | 2018-06-09 |
| Record revised | 2021-11-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Upright and with screw caps tightly closed; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10720808 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advin Multi-Drug Screen Test | Advin Biotech, Inc. | 75 |
| MD DugScreen | Medical Disposables Corp | 37 |
| Immunalysis | Immunalysis Corporation | 37 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 29 |
| DOA 6 Panel Test | Rapid Diagnostics, Inc. | 28 |
| First Sign® | Hemosure Inc. | 20 |
| Enzyme Immunoassay, Opiates | W.h.p.m., Inc. | 20 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 19 |
| MD DrugScreen | Medical Disposables Corp | 18 |
| DOA-7 Panel Test | Rapid Diagnostics, Inc. | 18 |
| DOA 5 Panel Test | Rapid Diagnostics, Inc. | 16 |
| Rapid Response | Btnx Inc. | 14 |
Showing 12 of 316. All products under Enzyme Immunoassay, Opiates
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221605 | 2023-07-25 |
| K172910 | 2017-10-18 |
| K150606 | 2015-10-23 |
| K102779 | 2011-03-18 |
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 | Closed |
|---|---|---|---|---|
| 2018-03-12 | Class III | Under Investigation by firm | Incorrect calibrator level listed in qualitative calibration steps | 2020-06-02 |
| 2018-03-12 | Class III | Under Investigation by firm | Incorrect calibrator level listed in qualitative calibration steps | 2020-06-02 |
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.