UF-Fluorocell CR
UF-Fluorocell CR is used to mark white blood cells, epithelial cells and bacteria, etc. in urine or in body fluids for determination of their counts with Sysmex fully automated urine…
UF-Fluorocell CR is used to mark white blood cells, epithelial cells and bacteria, etc. in urine or in body fluids for determination of their counts with Sysmex fully automated urine particle analyzers. UF-Fluorocell CR is intended for use only in conjunction with Sysmex diluent UF-CELLPACK CR.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
Record
| Listed by | Sysmex Corporation, Japan |
|---|---|
| FDA product code | GJH |
| Device type | Stain, Reticulocyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
| Record revised | 2023-06-02 (version 2) |
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 29 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AG792864 | Total Volume 29 ml | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alinity | Abbott Laboratories | 2 |
| Cell-DYN | Abbott Laboratories | 2 |
| Epredia | Richard-Allan Scientific LLC | 1 |
| UF-Fluorocell SF | Sysmex Corporation | 1 |
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.