Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

This category includes in vitro diagnostic kits designed to detect creatine kinase myocardial isoenzyme (CKMB) in clinical specimens. These tests are used to help evaluate suspected myocardial injury by measuring a specific cardiac biomarker. They operate using chemiluminescent immunoassay technology, which generates light signals proportional to the target analyte concentration.

These devices are supplied as complete reagent kits intended for use in clinical laboratory settings. They are classified as in vitro diagnostic medical devices and are regulated under applicable medical device frameworks. The test method relies on immunoassay principles, and the kits are typically used by trained laboratory personnel on automated analyzers.