AU
ISE Na+/K+ Selectivity Check Solution
2manufacturers in China registered for this device type
8catalogue numbers in this listing
3510(k) clearances naming this product code
3recalls 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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JGS |
| Device type | Electrode, Ion Specific, Sodium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1665 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AUH1011 | In distribution | |
| AUH1012 | In distribution | |
| AUH1014 | In distribution | |
| AUH1013 | In distribution | |
| AUH1016 | In distribution | |
| AUH1015 | In distribution | |
| AUH1018 | In distribution | |
| AUH1017 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 13 |
| i-STAT | Abbott Point OF Care Inc. | 9 |
| GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 | Instrumentation Laboratory SPA | 8 |
| Nova | Nova Biomedical Corporation | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 5 |
| Sodium Electrode | Roche Diagnostics Gmbh | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Sodium Electrode | Diamond Diagnostics Inc. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 2 |
| Sodium Electrode | Medica Corp. | 2 |
Showing 12 of 88. All products under Electrode, Ion Specific, Sodium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161837 | 2016-12-16 |
| K023049 | 2002-10-04 |
| K011213 | 2001-05-16 |
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 |
|---|---|---|---|---|---|
| 2010-10-22 | Not classified | Environmental control | This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified. | 1,410 units (503 in US) | 2014-09-02 |
| 2008-04-03 | Not classified | Nonconforming Material/Component | The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision. | 694 Worldwide; 656 in US & 38 in Canada total for all produc | 2011-11-29 |
| 2002-12-16 | Not classified | Other | The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence. | 1001 | 2004-12-01 |
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.