CELLPACK DST is a concentrated diluent for use in Sysmex Automated Hematology Analyzers and other Sysmex devices that use diluted CELLPACK DST. CELLPACK DST must only be used with the…
CELLPACK DST is a concentrated diluent for use in Sysmex Automated Hematology Analyzers and other Sysmex devices that use diluted CELLPACK DST. CELLPACK DST must only be used with the Reagent Preparation Units specified by Sysmex.
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
Record
Regulatory record for Cellpack DST | 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 | 2022-11-30 |
| 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 2 to 35 °C |
| Sizes | Total volume 4 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.