AST/GOT (IFCC)

Primary DI

16438153817717

Basic UDI-DI Code

6438153BU00160BQ

Reference

981771

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 aspartate aminotransferase (L-Aspartate: 2-Oxoglutarate Aminotransferase (AST), EC 2.6.1.1) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The AST/GOT test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of diseases, dystrophies and injuries of heart or skeletal muscle, in patients. Furthermore, the AST/GOT test is also indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of parenchymal liver diseases, like hepatic necrosis or (viral) hepatitis and kidney diseases, 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).