Alkaline Phosphatase (IFCC) Plus

Primary DI

16438153818325

Basic UDI-DI Code

6438153BU00156BZ

Reference

981832

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 alkaline phosphatase (orthophosphoric – monoester phospho-hydrolase, alkaline optimum, EC 3.1.3.1) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Alkaline Phosphatase test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of hepatobiliary diseases, such as cholestasis, tumors, inflammation or infectious hepatitis, in patients. Furthermore, the Alkaline Phosphatase test in indicated to be used in conjunction with clinical evaluation as an aid to diagnosis and monitoring of bone diseases associated with increased osteoblastic activity, in patients.

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).