Incup
Incup with THC/COC/OPI300/METH/BAR/MDMA/SVT
10manufacturers in China registered for this device type
35catalogue 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 | 2016-11-15 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10-3OC-200-S | 25 | In distribution | |
| 10-7SPC-221 | 25 | In distribution | |
| 10-10SPCA-356-S | 25 | In distribution | |
| 10-12XC-030 | 25 | In distribution | |
| 10-4BC-030 | 25 | In distribution | |
| 10-4OC-030 | 25 | In distribution | |
| 10-3MCA-000 | 25 | In distribution | |
| 10-5MC-200-S | 25 | In distribution | |
| 10-11SPCA-251-S | 25 | In distribution | |
| 10-2CMC-000 | 25 | In distribution | |
| 10-7SPCA-371 | 25 | In distribution | |
| 10-8XC-030 | 25 | In distribution | |
| 10-10DOC-030-S | 25 | In distribution | |
| 10-6SPCA-308 | 25 | In distribution | |
| 10-5MZC-030 | 25 | In distribution | |
| 10-10XCA-200-S | 25 | In distribution | |
| 10-6SPC-366 | 25 | In distribution | |
| 10-8XC-200-S | 25 | In distribution | |
| 10-6SPCA-099-S | 25 | In distribution | |
| 10-4MCA-030 | 25 | In distribution | |
| 10-6SPCA-176 | 25 | In distribution | |
| 10-10XC-200-S | 25 | In distribution | |
| 10-6SPC-307 | 25 | In distribution | |
| 10-3OC-030 | 25 | In distribution | |
| 10-8SPC-054 | 25 | In distribution | |
| 10-5ZCA-030 | 25 | In distribution | |
| 10-5SPCA-386 | 25 | In distribution | |
| 10-5PC-030 | 25 | In distribution | |
| 10-5PCA-200-S | 25 | In distribution | |
| 10-5SPC-382.5 | 25 | In distribution | |
| 10-8SPCA-220 | 25 | In distribution | |
| 10-9TC-030-S | 25 | In distribution | |
| 10-12XC-030-S | 25 | In distribution | |
| 10-6SPC-099-S | 25 | In distribution | |
| 10-6SPCA-376 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.