Lysercell WNR is a reagent product to be combined and used with Fluorocell WNR. By hemolyzing red blood cells with Lysercell WNR and by differentiating white blood cells (non-basophil),…
Lysercell WNR is a reagent product to be combined and used with Fluorocell WNR. By hemolyzing red blood cells with Lysercell WNR and by differentiating white blood cells (non-basophil), basophils, and nucleated red blood cells with Lysercell WNR and Fluorocell WNR, the white blood cell count, basophil count, basophil percentage, nucleated red blood cell count, and nucleated red blood cell percentage 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 WNR | 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 | 2022-11-30 |
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 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.