KHB(SZ:002022) Zheng Quan Shi Bao Wang·2024-11-20 07:54Core Viewpoint - Kehua Bio (002022) has received a medical device registration certificate from the Shanghai Municipal Medical Products Administration for its creatine kinase isoenzyme assay kit, which is used for auxiliary diagnosis of myocardial infarction and myopathy [1] Company Summary - The product, named creatine kinase isoenzyme assay kit (latex immunoturbidimetric method), is intended for the quantitative determination of creatine kinase isoenzyme levels in human serum or plasma samples [1] - The kit is designed for use in medical institutions, indicating a focus on the healthcare sector and potential market demand for diagnostic tools [1] Industry Summary - The approval of the assay kit highlights the growing importance of in vitro diagnostic products in clinical settings, particularly for conditions like myocardial infarction and muscle diseases [1] - This development may reflect broader trends in the medical device industry towards enhancing diagnostic capabilities and improving patient outcomes [1]