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