Chloride Electrode
3 catalogue numbers from 3246353001, listed by Roche Diagnostics Gmbh, Germany, under Electrode, Ion-Specific, Chloride. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | CGZ |
| Device type | Electrode, Ion-Specific, Chloride |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K060373 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 7 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3246353001 | In distribution | |
| 3003523001 | In distribution | |
| 03246353001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 14 |
| Nova | Nova Biomedical Corporation | 8 |
| Architect | Abbott Laboratories | 6 |
| Chloride Electrode | Medica Corp. | 3 |
| Chloride Electrode | Diamond Diagnostics Inc. | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| I.S.E. CL | Randox Laboratories Limited | 2 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| Na/K/Cl Solution Pack | Medica Corp. | 2 |
| Ready Sensor™ Gold Reference Sensor Refill | Siemens Healthcare Diagnostics Inc | 1 |
| I.S.E. REF | Randox Laboratories Limited | 1 |
| ABL90 Flex Plus | Radiometer Medical APS | 1 |
Showing 12 of 51. All products under Electrode, Ion-Specific, Chloride
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060108 | 2006-02-16 |
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.