Drew Scientific
EX Lyse (0.5L) Hematology Lysing Reagent
3manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | Drew Scientific, Ltd., United Kingdom |
|---|---|
| FDA product code | GGK |
| Device type | Products, Red-Cell Lysing Products |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8540 |
| Premarket notification | Exempt |
| Record published | 2016-09-09 |
| Record revised | 2026-05-18 (version 3) |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pink Kit Hemolyzer (440mL) | In distribution | |
| RA-9500 | In distribution | |
| EX-PAC2 | In distribution | |
| R12A24D-BUL | In distribution | |
| HEM2-125 | In distribution | |
| DREW3-PAC | In distribution | |
| RA-9020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cell-DYN | Abbott Laboratories | 14 |
| 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 |
| Coulter DxH Cell Lyse | 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.