Electrolyte Standard Kit
The Electrolyte Standard Kit is an in vitro diagnostic calibration material for serum electrolyte test systems. It is used to calibrate or verify calibration of sodium, potassium, lithium,…
The Electrolyte Standard Kit is an in vitro diagnostic calibration material for serum electrolyte test systems. It is used to calibrate or verify calibration of sodium, potassium, lithium, chloride and ionized calcium assays on compatible clinical chemistry instruments.
The kit contains aqueous primary standards with known amounts of their components. Concentrations are assigned by a gravimetric procedure, based on the weight per volume of source materials of known purity.
Assigned Values
Assigned concentrations are verified and lot-certified using NIST reference materials or equivalent primary standards when NIST materials are unavailable. Each kit includes a certificate of analysis describing the method used to verify the assigned concentration; compatible instrument models are specified in the package insert.
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Verichem Laboratories, Inc., United States |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K112834 |
| Record published | 2018-01-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 15 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 15 |
| Architect | Abbott Laboratories | 11 |
| Alinity | Abbott Medical | 10 |
| Synchron | Beckman Coulter, Inc. | 9 |
| Architect | Abbott Medical | 9 |
| Urine Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112834 | 2012-03-28 |
| K974290 | 1997-12-19 |
| K973345 | 1997-10-29 |
| K972333 | 1997-07-23 |
| K875285 | 1988-09-02 |
| K882116 | 1988-06-24 |
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.