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# DiaSorin Cytomegalovirus Assay for Infants Cleared
- URL: https://www.fdaweb.com/diasorin-cytomegalovirus-assay-for-infants-cleared/
- Published: 2022-11-11T12:00:00.000Z
- Updated: 2026-09-14T18:06:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153187

FDA has cleared a DiaSorin 510(k) for its Simplexa Congenital CMV Direct kit, a molecular diagnostic test that detects cytomegalovirus (CMV) DNA in saliva swab and urine specimens from infants that are 21 days old or younger. Saliva swab specimens are easy to collect for screening purposes and urine specimens are important for confirmation, DiaSorin says. The cleared assay is designed for use on the firm’s Liaison MDX instrument. “The Simplexa Congenital CMV Direct kit is the first FDA-cleared product for diagnosing congenital CMV from both saliva swab and urine specimens,” the company says.