Opti CCA E-Cl Cassette
Opti CCA E-Cl Cassette: 1 catalogue number listed by Opti Medical Systems Inc., United States, under Electrode, Ion-Specific, Chloride. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
2recalls on this code
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 | Opti Medical Systems Inc., United States |
|---|---|
| FDA product code | CGZ |
| Device type | Electrode, Ion-Specific, Chloride |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1170 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K131126 |
| Record published | 2019-09-03 |
| Record revised | 2022-12-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | 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 | 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-03-15 | Not classified | Nonconforming Material/Component | The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma. | 86 boxes (25 units (per box) | 2011-08-08 |
| 2009-04-20 | Not classified | Process control | Outer box labeling shows an incorrect storage temperature range. | 127 boxes of 25 cassettes each for a total of 3175 cassettes | 2012-04-17 |
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.