PAB · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3180
Classification
FDA Product Code
PAB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3180
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.