Phoenix Diagnostics, Inc.
Reference Electrode Cartridge for Roche / Hitachi Chemistry Systems
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
Record
| Listed by | Phoenix Diagnostics, Inc., United States |
|---|---|
| FDA product code | JJP |
| Device type | Electrode, Ion Selective (Non-Specified) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Manufacturer |
| 510(k) | K020148 |
| Record published | 2018-01-26 |
| Record revised | 2020-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E-930 | In distribution | |
| E-340 | In distribution | |
| E-330 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 6 |
| ABX Pentra Reference-E | Horiba ABX SAS | 1 |
| Reference Electrode | Jeol Ltd. | 1 |
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.