CK-MB Assay Kit CLIA

Primary DI

06974521001089

Basic UDI-DI Code

B-06974521001089

Reference

SUPM040072

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro quantitative detection of Creatine Kinase Isoenzyme (CK-MB) in human serum, plasma or whole blood samples. CK-MB mainly exists in the myocardium and accounts for 20% of CK total activity. The content of CK-MB in prostate glands, spleen and skeletal muscle is more than 5%, but it will change with the function of muscle. In case of acute myocardial infarction (AMI), CK-MB will appear in blood circulation, indicating that the myocardium is damaged. CK-MB sharply rises to the maximum value (in 12h) and then falls to the normal range (36-72h). Change of CK-MB is often deemed as AMI diagnosis with ECG evolution and chest pain history. Determination of CK-MB is oftel helpful for non-invasive evaluation on the effectiveness of repeated myocardial perfusion using thrombolytic therapy. Meanwhile, a rise of CK-MB content is related to muscle injury, but AMI shows no rise and fall of CK-MB content.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).