Stromatolyser-IM
STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Sysmex Corporation, Japan |
|---|---|
| FDA product code | GGK |
| Device type | Products, Red-Cell Lysing Products |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8540 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 30 °C |
| Sizes | Total volume 10 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIM-220A | Total Volume 10 l | In distribution |
| 93403213 | Total Volume 10 l | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K790029 | 1979-02-26 |
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.