Atellica Hema Diluent
AT HEMA Diluent 20L
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | GIF |
| Device type | Diluent, Blood Cell |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-02-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 18 to 25 °C; Storage environment temperature 18 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11374303 | In distribution | |
| 11374304 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Cellpack | Sysmex Corporation | 4 |
| Cellpack DST | Sysmex Corporation | 4 |
| Drew Scientific | Drew Scientific, Ltd. | 3 |
| Atellica IM Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| Cellpack DCL | Sysmex Corporation | 3 |
| SP | Cardinal Health 200, LLC | 3 |
| Needle Holder | Koros U.S.A., Inc. | 3 |
| Advia Centaur® Multi-Diluent 1 | Siemens Healthcare Diagnostics Inc | 3 |
| UF II Pack-SED | Sysmex Corporation | 2 |
| Cellsheath | Sysmex Corporation | 2 |
Showing 12 of 88. All products under Diluent, Blood Cell
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.