Phosphorus

Primary DI

16438153818912

Basic UDI-DI Code

6438153BU00183C4

Reference

981891

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

INTENDED PURPOSE / INTENDED USE: For in vitro diagnostic use in the quantitative determination of inorganic phosphate concentration in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Phosphorus test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of abnormal inorganic phosphate levels (hypophosphatemia or hyperphosphatemia), which can lead to significant bone disorders, in patients. Reasons of hypo- and hyperphosphatemia can be for example renal tubular defects, renal failure, respiratory alkalosis, parathyroid diseases or oncogenic osteomalacia.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).