Medical Device Network on MSN12h
AliveDx seeks FDA approval for MosaiQ AiPlex CTDplus assay
AliveDx has submitted a 510(k) premarket notification seeking approval from the US Food and Drug Administration (FDA) for its ...
AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) multiplex microarray
AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) microarray. The MosaiQ ...
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AliveDx gains IVDR CE mark for MosaiQ AiPlex CTDplus assay
AliveDx has obtained a CE mark under the EU's in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease (CTDplus) multiplex assay for use with its MosaiQ planar microarray ...
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AliveDx Submits Autoimmune Disease Test for FDA 510(k) Clearance
The Switzerland-based firm's MosaiQ AiPlex Connective Tissue Diseases (CTDplus) assay is used to aid the diagnosis of autoimmune diseases.