UF-CELLPACK CR is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell CR. UF-CELLPACK CR is used to mark formed…
UF-CELLPACK CR is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell CR. UF-CELLPACK CR is used to mark formed elements in urine (or in body fluid (cerebrospinal fluid, etc.)) for determination of nucleated specimens (white blood cells, epithelial cells and bacteria, etc.).
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
Record
Regulatory record for UF-Cellpack CR | 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 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.