FDA Classifies Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection 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 issued a final order classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection as a Class II device with special controls.
This decision was made after reviewing the Alethia CMV Assay Test System, submitted by Meridian Bioscience, Inc., which requested the De Novo classification in 2018. The FDA concluded that this classification wi . . .
This decision was made after reviewing the Alethia CMV Assay Test System, submitted by Meridian Bioscience, Inc., which requested the De Novo classification in 2018. The FDA concluded that this classification wi . . .