IVAX Diagnostics, Inc. Diamedix Subsidiary Files 510(k) Premarket Submission with FDA for Its Mago(R)4S
10/1/2009 9:42:38 AM
MIAMI--(BUSINESS WIRE)--IVAX Diagnostics, Inc. (AMEX: IVD) announced today that its U.S. subsidiary headquartered in Florida, Diamedix Corporation, has filed a 510(k) premarket submission with the U.S. Food and Drug Administration (“FDA”) for its next -generation fully automated Enzyme-linked Immunosorbent Assay (“ELISA”) system for autoimmune and infectious disease testing, named the Mago®4S. IVAX Diagnostics believes the new instrumentation will provide a flexible, efficient and cost-effective solution to today's high-performance laboratory demands.
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