AliveDx Receives the CE Mark Approval for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

Shots: AliveDx has received the European IVDR-CE mark approval for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture's) disease VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM VAS assay allows accurate serological evaluation with…

ByRidhi RastogiAugust 5, 2025

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

Shots: The US FDA has received 510(k) application for MosaiQ AiPlex CTDplus multiplex microarray to improve & accelerate diagnosis of connective tissue diseases (CTDs) CTDplus diagnose CTDs using just 10μL of sample in one step, with its CTD microarray having 15 markers in each panel per pts—DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P,…

ByRidhi RastogiApril 7, 2025

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Shots: The US FDA has received 510(k) Application for MosaiQ AiPlex Multiplex Microarray to improve & accelerate diagnosis of celiac disease MosaiQ simplifies serological evaluation with syndromic approach by combining IgA & IgG isotypes to detect IgA deficiency & measure anti-tTG as well as anti-DGP (AU/mL) using just 20 μL of sample in single…

ByRidhi RastogiFebruary 10, 2025

AliveDx Receives the CE Mark Approval for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

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