Ichem® Velocity™
iChem VELOCITY Urine Chemistry Strips
12manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (5), Zhejiang (2), Guangxi (1). 3 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 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Beckman Coulter Ireland Inc, Ireland |
|---|---|
| FDA product code | JJB |
| Device type | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1115 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-07 |
| Record revised | 2023-10-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| iChem VELOCITY Urine Chemistry Strips | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 3 |
| Rapid Response | Btnx Inc. | 2 |
| Stat Profile | Nova Biomedical Corporation | 2 |
| Clinitek Status Connector | Siemens Healthcare Diagnostics Inc | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
| Ictotest® Reagent Tablets and Mats for Urinalysis | Siemens Healthcare Diagnostics Inc | 1 |
| Urine Analyzer | Urit Medical Electronic Co., Ltd. | 1 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
| DxU | Beckman Coulter, Inc. | 1 |
| Diazo-Chek | Biorex Labs LLC | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | UDI-DI | 2020-02-17 | Class II | Under Investigation by firm | The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips. | 10822 vials | 2021-05-13 |
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.