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FDA Clears AutoGenomics' Infinity Analyzer

NEW YORK (GenomeWeb News) — AutoGenomics said today the US Food and Drug Administration has cleared its Infiniti Analyzer as a stand-alone instrument for multiplexed assays.
The FDA in February cleared AutoGenomics’ Infiniti Factor II and Factor V assays for diagnosing thrombophilia.
The company said it also has submitted a 510(k) application with the FDA for its Infiniti 2C9/VKORC1 multiplexed assay, which is used to assess sensitivity to the blood thinner warfarin.