AliveDx Submits 510(k) Application to FDA for MosaiQ AiPlex Vasculitis Assay
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AliveDx [Newsroom]Eysins, Switzerland (ots/PRNewswire) - AliveDx, the global in vitro diagnostic company that has set itself the goal of revolutionizing patient care, today announces that the US Food and Drug Administration ... Continue reading here...Original content of: AliveDx, transmitted by news up-to-date
AliveDx Submits 510(k) Application to FDA for MosaiQ AiPlex Vasculitis Assay
EYSINS, Switzerland – AliveDx has submitted a 510(k) pr […] The post AliveDx Submits 510(k) Application to FDA for MosaiQ AiPlex Vasculitis Assay first appeared on GeneOnline News. The post AliveDx Submits 510(k) Application to FDA for MosaiQ AiPlex Vasculitis Assay appeared first on GeneOnline News.
AliveDx, the global in vitro diagnostic company that aims to revolutionize patient care, today announces that it has submitted an application to the US Food and Drug Administration (FDA) for marketing authorisation (510(k)) for the MosaiQ AiPlex® Vasculitis (VAS) assay*. The MosaiQ AiPlex® VAS multiplex assay has been developed to investigate anti-MPO, anti-PR-3 and anti-GBM for ANCA-associated vasculitis (anti-neutr
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