CREATINE KINASE ISOENZYMES

Primary DI

D-02B0027YV

Basic UDI-DI Code

B-02B0027YV

Reference

3B001

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The cTnI/MYO/CKMB Reagent Kit is intended to quantitatively determine cTnI, MYO, or CKMB in human serum. Clinically, it is mainly used for auxiliary diagnosis of cardiomyopathy such as myocardial injury and acute myocardial infarction. Troponin I (cTnI) has high sensitivity, specificity and long-window period for myocardial injury. cTnI has become an important index for myocardial injury, especially the diagnosis of acute myocardial infarction, guidance treatment and prognosis, since it’s characterized by rapid occurrence and long duration in blood Myoglobin (MYO) is a protein in myocardium and skeletal muscle, which is poorly expressed in normal human serum. When myocardial and skeletal muscle are damaged, they can be released from damaged muscle cells. As a small molecular weight, MYO is easy to release into the blood circulation earlier. MYO begins to rise 2 ~ 3 hours after onset, reaches the peak after 7 ~ 10 hours, and returns to the reference range in about 24 hours in patients with acute myocardial infarction (AMI). The measurement of MYO level in serum is helpful to the diagnosis of myocardial infarction, muscular dystrophy, myocarditis and cardiomyopathy, and to the evaluation of disease treatment and prognosis. The elevation of creatine kinase MB isoenzyme (CKMB) in serum is recognized as an important index for the diagnosis of acute myocardial infarction and myocardial necrosis.

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