Research and Diagnostic Systems
Tech-Cal: 2 x 3.5mL Whole Blood Calibrator
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Guangdong (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 |
Record
| Listed by | Research AND Diagnostic Systems, Inc. |
|---|---|
| FDA product code | KSA |
| Device type | Calibrator For Red-Cell And White-Cell Counting |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8185 |
| 510(k) | K881161 |
| 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 |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 7 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TCV11 | Total Volume 7 ml | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cal-Chex A Plus | Streck LLC | 2 |
| SCS-1000 Calibrator | Sysmex Corporation | 1 |
| ABX Minocal | Horiba ABX SAS | 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.