FDA Classifies Device for Detecting Microbial Nucleic Acids by Fluorescence In Situ Hybridization Into Class II
May 09, 2025
May 09, 2025
WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has classified a new medical device used to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens as a class II device under special controls.
This action, announced on May 9, 2025, aims to provide a reasonable assurance of the device's safety and effectiveness while enhancing patient access to innovative medi . . .
This action, announced on May 9, 2025, aims to provide a reasonable assurance of the device's safety and effectiveness while enhancing patient access to innovative medi . . .