Phoenix Diagnostics
Fast Detergent 1 for Tokyo Boeki BiOLiS Series Chemistry Systems
5manufacturers in China registered for this device type
3catalogue 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 | Phoenix Diagnostics, Inc., United States |
|---|---|
| FDA product code | JCB |
| Device type | Detergent |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Manufacturer |
| 510(k) | K013451 |
| Record published | 2017-08-14 |
| Record revised | 2020-03-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C |
| Packaging | Case of 4, case of 14 |
| Sizes | Total volume 100 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 23-104 | In distribution | |
| 23-105 | In distribution | |
| 16-222 | Total Volume 100 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 9 |
| Cell-DYN | Abbott Laboratories | 7 |
| 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 |
| 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.