CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). This reagent is to…
CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex. Use as a sheath fluid for hematology analyzer.
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
Record
Regulatory record for Cellsheath | 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
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 1 to 30 °C |
| Sizes | Total volume 10 to 20 l |
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.