Cellsheath CCS
Concentrated diluent for use in hematology analyzers
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Sysmex Corporation, Japan |
|---|---|
| FDA product code | GIF |
| Device type | Diluent, Blood Cell |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8200 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-04 |
| Record revised | 2023-06-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 35 °C |
| Sizes | Total volume 20 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZA900004 | Total Volume 20 l | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Cellpack | Sysmex Corporation | 4 |
| Cellpack DST | Sysmex Corporation | 4 |
| Drew Scientific | Drew Scientific, Ltd. | 3 |
| Atellica IM Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| Cellpack DCL | Sysmex Corporation | 3 |
| SP | Cardinal Health 200, LLC | 3 |
| Needle Holder | Koros U.S.A., Inc. | 3 |
| Advia Centaur® Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| UF II Pack-SED | Sysmex Corporation | 2 |
| Cellsheath | Sysmex Corporation | 2 |
Showing 12 of 88. All products under Diluent, Blood Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K790028 | 1979-02-15 |
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.