Alinity
Alinity h-series Retic reagent
1manufacturer
2catalogue numbers in this listing
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 | Abbott Laboratories, United States |
|---|---|
| FDA product code | GJH |
| Device type | Stain, Reticulocyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-11-16 |
| Record revised | 2026-06-17 (version 4) |
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, serial number |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07P8004 | In distribution | |
| 06U8101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 2 |
| Epredia | Richard-Allan Scientific LLC | 1 |
| UF-Fluorocell SF | Sysmex Corporation | 1 |
| UF-Fluorocell CR | 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.