NEW YORK (360Dx) – Diazyme Laboratories said today that the US Food and Drug Administration has granted 510(k) clearance for its fully automated two-reagent EZ Vitamin D assay for use on validated clinical chemistry analyzers. 

Chong Yuan, managing director of Diazyme Laboratories, said in a statement that its system measures total 25-hydroxy vitamin D levels and enables clinical laboratories "of almost any size" to run a vitamin D test in house without the need for "expensive, specialized instrumentation."

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