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., Roche Molecular Systems, Inc. and Abbott Molecular, Inc..
FDA 510(k) Cleared Cytomegalovirus (cmv) Dna Quantitative Assay Devices (Product Code PAB)
About Product Code PAB - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PAB since 2025, with 3 receiving FDA clearance (average review time: 117 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
PAB devices are reviewed by the Microbiology panel. Browse all Microbiology devices →