CK-MB

Primary DI

05204309135639

Basic UDI-DI Code

5204309000015NP

Reference

1418-0299

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagents for In Vitro quantitative automated determination of the activity of Creatine Kinase-MB (CK-MB) in samples of human serum or plasma from the general patient population. Measurements of CK-MB are to be used as an aid to diagnosis and monitoring of conditions that require physicians to distinguish between skeletal muscle and heart muscle damage This product has been packed for use with BECKMAN COULTER AU series chemistry analyzers (AU600, AU600IVD, AU400, AU640, AU2700, AU5400, AU480, and AU680). For in vitro diagnostic use only by trained laboratory professionals.

The Basic UDI-DI associated with this device has 8 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).