FDA Product Code QDZ: Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies.
Leading manufacturers include Meridian Bioscience, Inc. and Diasorin Molecular, LLC.
2
Total
1
Cleared
449d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection Devices (Product Code QDZ)
2 devices
Cleared
Nov 05, 2022
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
Diasorin Molecular, LLC
Microbiology
775d
Not Cleared
Nov 30, 2018
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
Meridian Bioscience, Inc.
Microbiology
123d
About Product Code QDZ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QDZ since 2018, with 1 receiving FDA clearance (average review time: 449 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.