Aptima HIV-1 Quant Dx Assay
PMA: BP150318
Proper Name: None
Tradename: Aptima HIV-1 Quant Dx Assay
Manufacturer: Hologic, Inc.
Indications:
- An in vitro nucleic acid amplification test (NAAT) for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals on the fully automated Panther system.
Product Information
Supporting Documents
- November 5, 2020 Approval Order - Aptima HIV-1 Quant Dx Assay
- Supporting Documents older than three years - Aptima HIV-1 Quant Assay