Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF. By hemolyzing red blood cells with Lysercell WDF and dyeing the white blood cell component with Fluorocell…
Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF. By hemolyzing red blood cells with Lysercell WDF and dyeing the white blood cell component with Fluorocell WDF, the counts and percentages of neutrophils, lymphocytes, monocytes, and eosinophils are analyzed. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.
Who Else Makes It
Concentrated in Guangdong (1), Zhejiang (1), Shandong (1).
Record
Regulatory record for Lysercell WDF | Listed by | Sysmex Corporation, Japan |
| FDA product code | GGK |
| Device type | Products, Red-Cell Lysing Products |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8540 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-04 |
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 2 to 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.