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Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

FDA product code QDZ · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3181
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-11-05 – 2022-11-05

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

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