PAB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3180
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| cobas CMV (K252481) | Roche Molecular Systems, Inc. | 2025-11-03 |
| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
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