Urine Uric Acid Standard Kit
The Urine Uric Acid Standard Kit is an in vitro diagnostic reference material used to calibrate or verify the calibration of clinical chemistry test systems. The kit provides aqueous…
The Urine Uric Acid Standard Kit is an in vitro diagnostic reference material used to calibrate or verify the calibration of clinical chemistry test systems. The kit provides aqueous solutions containing known amounts of the relevant analyte.
Its assigned concentrations are established by weighing standard source materials of known purity and preparing a defined weight per volume composition. Those concentrations provide reference values against which the laboratory test system can be calibrated or checked.
Assigned Values
Each kit includes a certificate of analysis describing how its concentrations were verified. Lot values are checked using available NIST reference materials or equivalent primary standards, with reference method verification where available.
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 | 2016-11-29 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -25 to -15 °C |
| Sizes | Total volume 25 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9020 | Total Volume 25 ml | 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.