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FDA clears IVAX autoimmune disease test Mago 4S

IVAX Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval for Mago 4S, a fully-automated system for autoimmune and infectious disease testing.

Mago 4S is a next-generation system which can simultaneously process samples in enzyme-linked immunosorbent assay (ELISA) and immunofluorescence assay (IFA) instrumentation system methods.

The system features programming which facilitates interpretation, storage and recall of results, standard curves and internal quality control, and retrieval of archived data.

IVAX Diagnostics said the system is designed to provide a flexible, efficient and cost-effective solution to high-performance laboratory demands.