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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, SS-A 60, SS-B, TRIM21, Jo-1, CENP-B, Scl-70, & RNA Polymerase III
  • CTDplus allows accurate serological evaluation with rapid results, detecting ~1275 CTD markers/hr. with RFID-tagged reagents & magazines, accelerating the process to reduce time, consumables, & errors while improving calibration, quality control, & lab efficiency

Ref: AliveDx  | Image: AliveDx 

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

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