FDA Product Code PAB: Cytomegalovirus (cmv) Dna Quantitative Assay
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.
Leading manufacturers include Hologic, Inc. and Roche Molecular Systems, Inc..
List of Cytomegalovirus (cmv) Dna Quantitative Assay devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Cytomegalovirus (cmv) Dna Quantitative Assay devices (product code PAB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →