Calcium
Basic Information
- Primary DI
- 16438153007316
- Basic UDI-DI Code
- 6438153BU00127BS
- Reference
- 981953
- 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 USEโ: For in vitro diagnostic use in the quantitative determination of calcium concentration in human serum, plasma and urine with the automated procedures of Thermo Scientificโข Indikoโข and Konelabโข analyzers. The Calcium test for serum and plasma is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of decreased calcium levels (hypocalcemia) and increased calcium levels (hypercalcemia) due to various disorders and diseases of bone and parathyroid gland, gastrointestinal tract or kidney, in patients. Furthermore, the Calcium test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of vitamin D deficiency or resistance, which leads to hypocalcemia, in patients. The Calcium test for urine is indicated to be used in conjunction with clinical evaluation for aid to assess the excretion of calcium from the kidneys and for disease assessment, such as renal stone disease or high-turnover osteoporosis, in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010303 | CALCIUM |
Available In Countries
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