Diagnostic Kit for CK-MB (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521000525

Basic UDI-DI Code

B-06974521000525

Reference

SUPF019025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This test is suitable for in vitro quantitative detection of the concentration of creatine kinase MB isoenzyme(CK-MB) in human serum, plasma and whole blood. This product is used for testing in medical and health institutions for the auxiliary diagnosis of myocardial infarction. There are four isozymes of creatine kinase (CK): muscle type (mm), brain type (BB), hybrid type (MB) and mitochondria type (Mimi). MB type is mainly present in myocardial cells. During myocardial infarction, creatine kinase increase within 6 hours after onset, peak at 24 hours, and return to normal within 3-4 days. Among them, creatine kinase isoenzyme MB has high diagnostic specificity, so it has become one of the markers of myocardial infarction.

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