An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Approved Blood Products

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

Package Insert - Aptima HIV-1 Quant Dx Assay

Supporting Documents

November 5, 2020 Approval Order - Aptima HIV-1 Quant Dx Assay
Supporting Documents older than three years - Aptima HIV-1 Quant Assay

Top