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Cytomegalovirus (Cmv) Dna Quantitative Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

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Cytomegalovirus (Cmv) Dna Quantitative Assay
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PAB

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Class 2

21 CFR 866.3180

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Microbiology

Device Characteristics

No

No

No

Not Eligible

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.

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