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.