Uric Acid (AOX)
Basic Information
- Primary DI
- 16438153813917
- Basic UDI-DI Code
- 6438153BU00186CA
- Reference
- 981391
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Thermo Fisher Scientific Oy
Additional Description
INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of uric acid concentration in human serum, plasma and urine with the automated procedures of Thermo Scientificโข Indikoโข and Konelabโข analyzers. The Uric Acid (AOX) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of gout diseases, due to hyperuricemia, in patients. Hyperuricemia may be caused for example by acute or chronic kidney disease or increased nucleic acid turnover because of e.g. malignant diseases (leukemia, myeloma), in patients. Furthermore, the urine Uric Acid (AOX) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of the cause of hyperuricemia and for assessing the risk of renal stone formation, in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010232 | URIC ACID |
Available In Countries
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The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).