PAB
- Product code
- PAB
- Device name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3180
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252481 | 2025-11-03 | Roche Molecular Systems, Inc. | cobas CMV | |
| K243485 | 2025-07-01 | Abbott Molecular, Inc. | Alinity m CMV | |
| K243935 | 2025-01-17 | Hologic, Inc. | Aptima CMV Quant Assay |
Official FDA classification page: PAB
Classification and pathway per current FDA publications. Data from openFDA (CC0).