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Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA product code PAB · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3180
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-01-17 – 2025-11-03

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.

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