BK231025 - Aptima HIV-1 Quant Dx Assay
510(k) Number: BK231025
Applicant: Hologic, Inc.
Device Name: Aptima® HIV-1 Quant Dx Assay
Decision Date: 8/6/2024
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.