DRI Propoxyphene Assay
3 catalogue numbers from 0433, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Propoxyphene. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Microgenics Corporation, United States |
|---|---|
| FDA product code | JXN |
| Device type | Enzyme Immunoassay, Propoxyphene |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3700 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K943414 |
| Record published | 2016-09-12 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0433 | In distribution | |
| 0432 | In distribution | |
| 10018510 | 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 |
|---|---|
| K951133 | 1995-05-02 |
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.