Cell-DYN
CELL-DYN Emerald 22 Easy Cleaner
5manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JCB |
| Device type | Detergent |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-09 |
| Record revised | 2023-06-02 (version 5) |
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, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 4 |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 99644-01 | In distribution | |
| 09H6003 | In distribution | |
| 09H46-02 | In distribution | |
| 99326-02 | Withdrawn | |
| 99320-01 | Withdrawn | |
| 09H60-01 | Withdrawn | |
| 99321-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 9 |
| Coulter Clenz Cleaning Agent | Beckman Coulter, Inc. | 5 |
| Surgical Milk | Germiphene Corp. | 4 |
| Drew Scientific | Drew Scientific, Ltd. | 4 |
| ET Foam | Germiphene Corp. | 4 |
| JAS Diagnostics | Drew Scientific, Ltd. | 3 |
| Carolina Liquid Chemistries Corp.® Wash Concentrate ST160 | Carolina Liquid Chemistries | 3 |
| DxU | Beckman Coulter, Inc. | 3 |
| Detergent for Automatic Urine Analyzer | Urit Medical Electronic Co., Ltd. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 3 |
| Good Vibrations | MicroCare Medical | 3 |
| Coulter DxH Cleaner | Beckman Coulter, Inc. | 2 |
Showing 12 of 56. All products under Detergent
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.