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U.S. Department of Health and Human Services

Product Classification

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Device cytomegalovirus (cmv) dna quantitative assay
Definition Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma or whole blood. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Physical State IVD
Technical Method In vitro nucleic acid based assay using real-time PCR for the quantitative measurement of CMV DNA
Target Area Not Applicable
Review Panel Microbiology
Product CodePAB
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible