510(k) DEN180040

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit by Meridian Bioscience, Inc. — Product Code QDZ

DEN180040 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit". The FDA issued a decision of De Novo Granted on November 30, 2018. The device falls under product code QDZ (Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection), a Class II device regulated under 21 CFR 866.3181. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.