Diazyme Laboratories, Inc. CARDIAC TROPONIN I ASSAY
The Diazyme Cardiac Troponin I Assay (DZ145A-K) is an in vitro diagnostic test intended for the quantitative determination of cardiac troponin I (cTnI) in human serum or plasma. This assay is designed for use on automated clinical chemistry analyzers and is utilized as an aid in the diagnosis of myocardial infarction and other cardiac-related conditions. The test employs a latex-enhanced immunoturbidimetric method, providing high sensitivity and specificity for cTnI detection. The kit includes reagents and calibrators necessary for the assay, and is intended for professional use in clinical laboratories. The assay is CE marked and complies with relevant regulatory standards.