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.
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
No devices found for this product code.
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.