IVAX Diagnostics Receives F.D.A. Clearance for Mago® 4S (IVD)

IVAX Diagnostics, Inc. IVD today announced that it has received clearance from the United States Food and Drug Administration (FDA) on the 510(k) premarket submission that IVAX Diagnostics had filed for the Mago® 4S. The Mago® 4S is IVAX Diagnostics' next-generation fully-automated Enzyme-linked Immunosorbent Assay (ELISA) and Immunofluorescence Assay (IFA) instrumentation system for autoimmune and infectious disease testing that IVAX Diagnostics intends to market in the United States.