Device |
qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection |
Definition |
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies. |
Physical State |
In vitro diagnostic device |
Technical Method |
Qualitative DNA amplification technology |
Target Area |
Human clinical specimens |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QDZ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3181
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |