Osang Healthcare (036220) announced on the 18th that it is currently undergoing clinical trials and regulatory approval procedures for its next-generation diabetes diagnostic multi-parameter analyzer, the “CLOVER DX D1,” which is poised to make a quantum leap in the HbA1c meter market.
This device is a multi-parameter analyzer capable of simultaneously measuring various markers, including HbA1c, albumin-to-creatinine ratio (ACR), and C-reactive protein (CRP). The company aims to obtain certification under the European In Vitro Diagnostic Medical Devices Regulation (CE-IVDR) and U.S. Food and Drug Administration (FDA) 510(k), as well as a U.S. Clinical Laboratory Improvement Amendments (CLIA) waiver.