DrugCheck
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY
17manufacturers in China registered for this device type
29catalogue numbers in this listing
1recall
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 | Express Diagnostics Int’l., Inc. |
|---|---|
| FDA product code | DJG |
| Device type | Enzyme Immunoassay, Opiates |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3650 |
| Record published | 2016-08-29 |
| Record revised | 2022-06-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
| Distribution end date | 2019-04-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30160 | Withdrawn | |
| 60775 | Withdrawn | |
| 30524 | Withdrawn | |
| 30199C | Withdrawn | |
| 30202 | Withdrawn | |
| 60525 | Withdrawn | |
| 30460 | Withdrawn | |
| 30210 | Withdrawn | |
| 30111C | Withdrawn | |
| 30111 | Withdrawn | |
| 30710 | Withdrawn | |
| 60659 | Withdrawn | |
| 60533 | Withdrawn | |
| 30427 | Withdrawn | |
| 30620 | Withdrawn | |
| 30402 | Withdrawn | |
| 30319 | Withdrawn | |
| 30163 | Withdrawn | |
| 30163C | Withdrawn | |
| 30325 | Withdrawn | |
| 30414 | Withdrawn | |
| 30309 | Withdrawn | |
| 60907 | Withdrawn | |
| 30501 | Withdrawn | |
| 30199 | Withdrawn | |
| 60205 | Withdrawn | |
| 30311 | Withdrawn | |
| 30160C | Withdrawn | |
| 30212 | Withdrawn |
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 |
| 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 |
| DOA 4 Panel Test | Rapid Diagnostics, Inc. | 13 |
Showing 12 of 316. All products under Enzyme Immunoassay, Opiates
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-03-18 | Not classified | Incorrect or no expiration date | Express Diagnostics Int’l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices, This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product ma | 6925 devices | 2012-07-06 |
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.