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U.S. Department of Health and Human Services

Product Classification

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Device cytomegalovirus (cmv) dna quantitative assay
Regulation Description Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
Definition Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. 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
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePAB
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3180
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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