FDA 510(k) Applications for Medical Device Product Code "QDZ"

FDA 510(k) Number Applicant Device Name Decision Date
K202755 DiaSorin Molecular LLC Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack 11/05/2022
DEN180040 Meridian Bioscience, Inc. Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit 11/30/2018


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