AliveDx seeks FDA approval for MosaiQ AiPlex CTDplus assay

AliveDx seeks FDA approval for MosaiQ AiPlex CTDplus assay

AliveDx has submitted a 510(k) premarket notification seeking approval from the FDA for its MosaiQ AiPlex CTDplus microarray.The post AliveDx seeks FDA approval for MosaiQ AiPlex CTDplus assay appeared first on Medical Device Network.

AliveDx [Newsroom]Eysins, Switzerland (ots/PRNewswire) - Today, AliveDx announced that the US Food and Drug Administration (FDA) has filed a 510(k) pre-market notification for the MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) ... Continue reading here...Original content of: AliveDx, transmitted by news up-to-date

HATE GAB ALIVEDX RECOGNISES that IN THE US-AMERICAN FOOD AND DRUG ADMINISTRATION (FDA) A 510(K) MICROARRAY MOSAIQ AIPLEX® CONNECTIVE TISSUE DISEASES (CTDPLUS) MICROARRAY MOSAIQ AIPLEX CTDPLUS MULTIPLEX-ASSAY, which has received IVDR-CE-CERTIFICATION in FEBRUARY 2025, WAS DEVELOPED TO IMPROVE THE SAFETY AND SHEET OF THE SYSTEMATICAL DIAGNOSIS OF INDIVIDUAL DISCANCES AND TO DETERMATE THE LABORATORY LABORATORY LABORATORY.