Cell-DYN
CELL-DYN Ruby, CELL-DYN 3200 System CN-FREE HGB/NOC LYSE
3manufacturers in China registered for this device type
14catalogue numbers in this listing
1recall
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 | Abbott Laboratories, United States |
|---|---|
| FDA product code | GGK |
| Device type | Products, Red-Cell Lysing Products |
| Device class | Class 1 |
| Regulation | 21 CFR 864.8540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-07-15 |
| Record revised | 2022-06-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 2 to 25 °C |
| Packaging | Case of 4 |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09H6102 | In distribution | |
| 01H78-02 | In distribution | |
| 08H52-01 | In distribution | |
| 09H47-02 | In distribution | |
| 09H6101 | In distribution | |
| 03H80-02 | In distribution | |
| 01H79-01 | In distribution | |
| 01H77-02 | In distribution | |
| 99431-01 | Withdrawn | |
| 03H78-01 | Withdrawn | |
| 99311-01 | Withdrawn | |
| 07H84-01 | Withdrawn | |
| 03H62-01 | Withdrawn | |
| 07H84-02 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Coulter DxH Cell Lyse | Beckman Coulter, Inc. | 2 |
Showing 12 of 79. All products under Products, Red-Cell Lysing Products
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-12-19 | Not classified | Material/Component Contamination | Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination. | Product was distributed in the follow amounts: 1,199 botttle | 2008-07-02 |
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.