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U.S. Department of Health and Human Services

Product Classification
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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 CodeQDZ
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
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