Rtcii 2nd Gen.
7 Drug Minicup COC150/METH500/OPI300 AMP500/PCP/BAR/BZO
12manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (3), Beijing (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 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| 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 | DIS |
| Device type | Enzyme Immunoassay, Barbiturate |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3150 |
| 510(k) | K170222 |
| Record published | 2017-10-06 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F; Handling environment temperature 59 to 86 °F; Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10-7MBZ3-030 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MD DugScreen | Medical Disposables Corp | 9 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 7 |
| Healgen | Healgen Scientific Limited Liability Company | 6 |
| ProScreen | Instant Tech Subsidiary Acquisition | 5 |
| EZ-Screen® CUP | Medtox Diagnostics, Inc. | 5 |
| Immunalysis | Immunalysis Corporation | 4 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 4 |
| MD DrugScreen | Medical Disposables Corp | 4 |
| QuickTox Drug Screen Dipcard | Ameditech, Inc. | 4 |
| TOX/See | Bio-Rad Laboratories Inc. | 3 |
| DRI Barbiturate Assay | Microgenics Corporation | 3 |
| QuickTox Drug Screen Dipcard | Branan Medical Corporation | 3 |
Showing 12 of 102. All products under Enzyme Immunoassay, Barbiturate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041712 | 2004-11-03 |
| K992451 | 2000-04-03 |
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.