Rtcii 1st Gen.
Rtcii 1ST GEN THC/COC/METH/OPI300/AMP/BZO/ OXY/BAR/MTD/PCP/PPX/SVT
10manufacturers in China registered for this device type
23catalogue 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 | American Bio Medica Corp., United States |
|---|---|
| FDA product code | JXN |
| Device type | Enzyme Immunoassay, Propoxyphene |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3700 |
| 510(k) | K073078 |
| Record published | 2019-10-03 |
| 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 | Handling environment temperature 59 to 86 °F; Handling environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Distribution end date | 2017-09-29 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10-4PX2A-200 | 25 | In distribution | |
| 10-6MZX2A-030 | 25 | In distribution | |
| 10-6MZX2B-515 | 200 | In distribution | |
| 10-6ZOX2B-030 | 200 | In distribution | |
| 10-10XX2-030 | 25 | In distribution | |
| 10-6ZOX2-030 | 25 | In distribution | |
| 10-6MZX2-030 | 25 | In distribution | |
| 10-10SPX2-379 | 25 | In distribution | |
| 10-6SX2-515 | 25 | In distribution | |
| 10-5PX2A-200 | 25 | In distribution | |
| 10-11SPX2A-516 | 25 | In distribution | |
| 10-4MX2-030 | 25 | In distribution | |
| 10-8MZX2A-030 | 25 | In distribution | |
| 10-8SPX2-347 | 25 | In distribution | |
| 10-7SPX2-112 | 25 | In distribution | |
| 10-10SPX2B-339 | 200 | In distribution | |
| 10-10SPX2B-381 | 200 | In distribution | |
| 10-10XX2B-030 | 200 | In distribution | |
| 10-6SX2AB-030 | 200 | In distribution | |
| 10-11SPX2-343 | 25 | In distribution | |
| 10-8SPX2B-390 | 200 | In distribution | |
| 10-10SPX2A-339 | 25 | In distribution | |
| 10-7MZX2AB-113 | 200 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Incup | American Bio Medica Corp. | 35 |
| 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 |
| DRI Propoxyphene Assay | Microgenics Corporation | 3 |
Showing 12 of 69. All products under Enzyme Immunoassay, Propoxyphene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030835 | 2003-05-22 |
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.