Cal-Chex a Plus
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
3manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
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 | Streck LLC, United States |
|---|---|
| FDA product code | KRX |
| Device type | Calibrator For Cell Indices |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8150 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2026-05-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C |
| Sizes | Total volume 3 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 221108 | Total Volume 3.0 ml | 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 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 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160585 | 2016-12-22 |
| K141955 | 2014-12-05 |
| K141962 | 2014-12-05 |
| K120747 | 2012-10-22 |
| K120745 | 2012-10-19 |
| K111204 | 2011-12-22 |
| K083200 | 2009-02-03 |
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.