Aptima CMV Quant Assay
FDA premarket approval P210029 · decided 2022-05-09
Approval details
- PMA number
- P210029
- Trade name
- Aptima CMV Quant Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Hologic, Inc.
- Date received
- 2021-07-26
- Decision date
- 2022-05-09
- Days to decision
- 287 days
- Decision code
- APRL
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval of The Aptima CMV Quant Assay - This device is approved for:The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther system. The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess
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