![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Clears Inova Diagnotics’ Assays
FDA Clears Inova Diagnotics’ Assays
![FDA_Logo_Black_2016.gif](https://www.fdanews.com/ext/resources/test/Drug-Images4/FDA_Logo_Black_2016.gif?t=1579040596&width=430)
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
Upcoming Events
-
21Oct