SC-CAL Plus Calibrator
Catalogue number SC-CAL PLUS, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, 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 | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | KRX |
| Device type | Calibrator For Cell Indices |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8150 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K955925 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC-CAL PLUS | In distribution |
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 | 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 |
| One Step Plus KIT | Bisco, Inc. | 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.