CL Electrode, ISE Module
Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride…
Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
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 | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag |
|---|---|
| FDA product code | CGZ |
| Device type | Electrode, Ion-Specific, Chloride |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1170 |
| 510(k) | K101741 |
| Record published | 2016-10-06 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 25 °C |
| Packaging | Box |
| Sizes | Height 60 mm; depth 40 mm; width 90 mm |
| Distribution end date | 2025-11-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cl- Electrode | Height 60 mm | Withdrawn |
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 | Roche Diagnostics Gmbh | 3 |
| 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 |
Showing 12 of 51. All products under Electrode, Ion-Specific, Chloride
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.