Albumin MST
Basic Information
- Primary DI
- 16438153819278
- Basic UDI-DI Code
- 6438153BU00152BR
- Reference
- 981927
- 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 low albumin concentration in human urine with the automated procedure of Thermo Scientificโข Indikoโข and Konelabโข analyzers, and for the quantitative determination of albumin concentration in human serum and plasma with the automated procedures of Thermo Scientificโข Konelabโข analyzer. The urine Albumin MST test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of albuminuria, caused by renal damage due to e.g. diabetes, hypertension, minor glomerulus lesion or inhibition of reabsorption, in patients. The urine Albumin MST test is furthermore indicated to be used in conjunction with clinical evaluation for aid to early diagnosis and predicting of diabetic nephropathy and end-stage renal disease, in patients. The serum and plasma Albumin MST test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of a multitude of clinical conditions correlating with decreased albumin levels, such as hepatic- and renal functional status, nutritional- and fluid balance and inflammation, in patients. Furthermore, the serum and plasma Albumin MST test is indicated be used in conjunction with clinical evaluation for aid to diagnosis of analbuminemia, in patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010309 | ALBUMIN (IC) INCL. UALBUMIN |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).