FDA Clears Inova Diagnotics’ Assays

San Diego–based, Inova Diagnostics has won FDA marketing clearance for its NOVA Lite DAPI ANCA (ethanol) and NOVA Lite DAPI ANCA (formalin) kits for use with NOVA View, a digital IFA (immunofluorescence assay) microscope.

The device kits are reagents for the detection of anti-neutrophil cytoplasmic antibodies (ANCA) on an automated digital IFA microscope. — Cynthia Jessup