Propoxyphene
Catalogue number 20753602122, listed by Roche Diagnostics Gmbh, Germany, under Enzyme Immunoassay, Propoxyphene. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JXN |
| Device type | Enzyme Immunoassay, Propoxyphene |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K954992 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20753602122 | In distribution |
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 |
| DrugCheck | Express Diagnostics Int’l., 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 |
Showing 12 of 69. All products under Enzyme Immunoassay, Propoxyphene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K043303 | 2005-03-11 |
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.