Atellica Hema Diff
AT HEMA Diff
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Zhejiang (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | GGK |
| Device type | Products, Red-Cell Lysing Products |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8540 |
| 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 | Storage environment temperature 18 to 25 °C; Handling environment temperature 18 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 11374310 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 14 |
| Drew Scientific | Drew Scientific, Ltd. | 7 |
| Beckmancoulter | Immunotech Corp. | 4 |
| Coulter Lyse S III diff Lytic Reagent | Beckman Coulter, Inc. | 4 |
| Lysercell WDF | Sysmex Corporation | 4 |
| Beckman coulter | Immunotech Corp. | 4 |
| STROMATOLYSER-4DL | Sysmex Corporation | 3 |
| M-30CFL Lyse | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 3 |
| Sulfolyser | Sysmex Corporation | 3 |
| Coulter Lyse S 4 Lytic Reagent | Beckman Coulter, Inc. | 2 |
| M-5LEO(II) Lyse | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| Coulter diff Ac•T PAK Reagent Kit | Beckman Coulter, Inc. | 2 |
Showing 12 of 79. All products under Products, Red-Cell Lysing Products
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.