CK-MB

Primary DI

16438153818349

Basic UDI-DI Code

6438153BU00052BL

Reference

981834

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of CK-MB (B subunit of the isoenzyme CK-MB of creatine kinase, ATP: Creatine N-Phosphotransferase (CK), EC 2.7.3.2) activity in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The CK-MB test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of heart injury and skeletal muscle damage, 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 C) and regulation (EU IVDR).