DrugCheck
8 Panel Dip Drug Test, AMP-BAR-BUP-MDMA-MTD-OXY-PCP-PPX
10manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (5), Guangdong (3), Jilin (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 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| 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 | Express Diagnostics Int’l., Inc. |
|---|---|
| FDA product code | JXN |
| Device type | Enzyme Immunoassay, Propoxyphene |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3700 |
| 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 |
|---|---|---|
| 30803 | Withdrawn | |
| 30195 | Withdrawn | |
| 30195C | Withdrawn | |
| 30207 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Incup | American Bio Medica Corp. | 35 |
| Rtcii 1st gen. | American Bio Medica Corp. | 23 |
| Healgen | Healgen Scientific Limited Liability Company | 18 |
| DrugSmart Cup | Twin Spirit Inc. | 6 |
| ProScreen | Instant Tech Subsidiary Acquisition | 6 |
| ToxCup Drug Screen Cup | Branan Medical Corporation | 5 |
| McKesson | Mckesson Medical-Surgical Inc. | 4 |
| Rtcii 2nd gen. | American Bio Medica Corp. | 4 |
| RDS | American Bio Medica Corp. | 3 |
| Profile-II ER® | Medtox Diagnostics, Inc. | 3 |
| Syva® Emit® II Plus Propoxyphene Assay | Siemens Healthcare Diagnostics Inc | 3 |
| DRI Propoxyphene Assay | Microgenics Corporation | 3 |
Showing 12 of 69. All products under Enzyme Immunoassay, Propoxyphene
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 |
|---|---|---|---|---|---|
| 2010-10-04 | Not classified | Labeling False and Misleading | Express Diagnostics Int’l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as “forensic use only”, meaning they cannot be distributed or used for treatme | 196,750 | 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.