XN CAL PF
XN CAL PF 5X3.0ML
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Sysmex Corporation, Japan |
|---|---|
| FDA product code | KRX |
| Device type | Calibrator For Cell Indices |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8150 |
| Establishment | Manufacturer, Exporter |
| Record published | 2017-10-06 |
| Record revised | 2018-09-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 3 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 213537 | Total Volume 3 ml | In distribution |
| 213536 | Total Volume 3 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 11 |
| 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 |
| 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.