CELLPACK DFL is a reagent used in combination with Fluorocell RET for the analysis of reticulocytes or with Fluorocell PLT for the analysis of platelets by flow cytometry method using a…
CELLPACK DFL is a reagent used in combination with Fluorocell RET for the analysis of reticulocytes or with Fluorocell PLT for the analysis of platelets by flow cytometry method using a semiconductor laser. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
Record
Regulatory record for Cellpack DFL | 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 |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 35 °C |
| Sizes | Total volume 1 to 1.5 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.