510(k) DEN180040
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 30, 2018
- Date Received
- July 30, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- Device Class
- Class II
- Regulation Number
- 866.3181
- Review Panel
- MI
- Submission Type
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.