UFII PACK -SED is a diluent for Sysmex fully automated urine particle analyzers, and is intended for use only in conjunction with UFII SEARCH -SED. UFII PACK -SED dilutes the aspirated…
UFII PACK -SED is a diluent for Sysmex fully automated urine particle analyzers, and is intended for use only in conjunction with UFII SEARCH -SED. UFII PACK -SED dilutes the aspirated sample for the determination of the parameters, Red Blood Cell (RBC), White Blood Cell (WBC), Epithelial Cells (EC) and Casts (CAST) count, by fluorescence flow cytometry method.
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
Record
Regulatory record for UF II Pack-SED | 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 |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 35 °C |
| Sizes | Total volume 2.1 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.