IntraStain
Catalogue number K2311, listed by Agilent Technologies Singapore (International) Pte Ltd., Singapore, under Products, Red-Cell Lysing Products. 3 manufacturers in China are registered for this product code.
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 | Agilent Technologies Singapore (International) Pte Ltd., Singapore |
|---|---|
| FDA product code | GGK |
| Device type | Products, Red-Cell Lysing Products |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-17 |
| Record revised | 2020-12-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K2311 | 100 Tests | 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.