ABX Pentra Reference-E
Catalogue number 3014029451, listed by Horiba ABX SAS, France, under Electrode, Ion Selective (Non-Specified). 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
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 | Horiba ABX SAS, France |
|---|---|
| FDA product code | JJP |
| Device type | Electrode, Ion Selective (Non-Specified) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K052007 |
| Record published | 2016-08-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3014029451 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 3 |
| 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.