Research and Diagnostic Systems
NEK-Cal: 2 x 3.5mL Tubes NEK-Cal (calibrator)
3manufacturers in China registered for this device type
11catalogue 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 | Research AND Diagnostic Systems, Inc. |
|---|---|
| FDA product code | KRX |
| Device type | Calibrator For Cell Indices |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8150 |
| 510(k) | K003991 |
| Record published | 2016-07-29 |
| Record revised | 2018-07-06 (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; Handling environment temperature 2 to 8 °C |
| Sizes | Total volume 3 to 18 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8CP12 | Total Volume 4 ml | 2 | In distribution |
| 3KC11 | Total Volume 6 ml | 2 | In distribution |
| 8CP33 | Total Volume 18 ml | 3 | In distribution |
| 0CP020TA3 | In distribution | ||
| 8CP15 | Total Volume 6 ml | 2 | In distribution |
| 3KC12 | Total Volume 15 ml | 5 | In distribution |
| 8CP01 | Total Volume 3 ml | In distribution | |
| NEK11 | Total Volume 7 ml | 2 | In distribution |
| 8CP13US | Total Volume 6 ml | 2 | In distribution |
| 8CD02 | Total Volume 6 ml | 2 | In distribution |
| 0CP010TA3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.