510(k) K202755

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack by Diasorin Molecular, LLC — Product Code QDZ

K202755 is an FDA 510(k) premarket notification submitted by Diasorin Molecular, LLC for the device "Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack". The FDA issued a decision of Substantially Equivalent on November 5, 2022. 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. Diasorin Molecular, LLC has at least 10 other 510(k) clearances on record.