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QDZ — Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection Class II

FDA Device Classification

Classification Details

Product Code
QDZ
Device Class
Class II
Regulation Number
866.3181
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K202755diasorin molecularSimplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackNovember 5, 2022
DEN180040meridian bioscienceAlethia CMV DNA Amplification Assay, Alethia CMV External Control KitNovember 30, 2018