Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA product code PAB · Class II (moderate risk) · 21 CFR 866.3180 · Microbiology
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.
3510(k) clearances
6PMA approvals
1recalls
Manufacturers
510(k) clearances
PMA approvals
- P210029 Aptima CMV Quant Assay · Hologic, Inc. · 05/09/2022
- P210022 Alinity m CMV · Abbott Molecular, Inc. · 05/05/2022
- P160041 Cobas CMV · Roche Molecular Systems, Inc. · 06/01/2017
- P160044 Abbott Realtime CMV · Abbott Molecular · 05/18/2017
- P130027 Artus CMV RGQ MDX Kit · Qiagen, Inc. · 06/02/2014
- P110037 Cobas® Ampliprep/Cobas® Taqman® CMV Test (Cap/Ctm CMV Test) · Roche Molecular Systems, Inc. · 07/05/2012
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1371-2024 Class II | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001…Use of assay along with plasma specimen may result in error code which would invalidate sample. | Hologic, Inc. | 09/14/2023Open, Classified |