One Step Plus KIT
Catalogue number U-2260K, listed by Bisco, Inc., United States, under Calibrator For Cell Indices. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Bisco, Inc., United States |
|---|---|
| FDA product code | KRX |
| Device type | Calibrator For Cell Indices |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2017-06-12 |
| Record revised | 2024-02-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Distribution end date | 2018-06-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U-2260K | sixe text | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 11 |
| XN CAL PF | Sysmex Corporation | 2 |
| X-CAL Calibrator | Sysmex Corporation | 2 |
| Minocal | Horiba Instruments Incorporated | 2 |
| XN CAL | Sysmex Corporation | 2 |
| SC-CAL Plus Calibrator | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| SC-CAL Plus | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Coulter AcT | Beckman Coulter, Inc. | 1 |
| Cal-Chex A Plus | Streck LLC | 1 |
| Cell-DYN | Abbott Laboratories | 1 |
| CDS-LTX Control | Clinical Diagnostic Solutions, Inc. | 1 |
| Drew Scientific | Drew Scientific, Ltd. | 1 |
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.