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# FDA Clears Meridian Congenital Cytomegalovirus Assay
- URL: https://www.fdaweb.com/fda-clears-meridian-congenital-cytomegalovirus-assay/
- Published: 2018-12-06T12:00:00.000Z
- Updated: 2026-09-15T00:49:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142975

FDA has cleared a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test. This assay is designed to detect congenital cytomegalovirus (cCMV) infection in newborns from a saliva sample. It is the first qualitative test in a molecular amplification format cleared for cCMV testing in newborns, the company says. Congenital CMV is the most common congenital infection and a leading cause of childhood hearing loss, cognitive deficits, and visual impairment, it adds.