PAB — Cytomegalovirus (Cmv) Dna Quantitative Assay Class II
FDA product code PAB covers "Cytomegalovirus (Cmv) Dna Quantitative Assay", a Class II medical device regulated under 21 CFR 866.3180. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PAB
- Device Class
- Class II
- Regulation Number
- 866.3180
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.