AccuSign® BAR Card
AccuSign® BAR card; 10 Test kit; CE
12manufacturers in China registered for this device type
2catalogue numbers in this listing
6510(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 | Princeton BioMeditech Corp., United States |
|---|---|
| FDA product code | DIS |
| Device type | Enzyme Immunoassay, Barbiturate |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3150 |
| Establishment | Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DOA-206-10-02 | In distribution | |
| DOA-206-35-02 | 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 |
|---|---|
| K991082 | 1999-04-15 |
| K991076 | 1999-04-15 |
| K991084 | 1999-04-15 |
| K991018 | 1999-04-15 |
| K962669 | 1996-08-15 |
| K961010 | 1996-06-28 |
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.