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.

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.

In this section: Approved Blood Products

NucliSens HIV-1 QT

Proper Name: NucliSens HIV-1 QT
Tradename: NucliSens HIV-1 QT
Manufacturer: bioMerieux, Inc.
Indication:

In conjunction with clinical presentation and other laboratory markers of disease progression for prognostic assessment of HIV-1 infected patients, and for monitoring the effects of anti-retroviral therapy by serial measurements of plasma HIV-1 RNA for pediatric and adult patients with baseline viral loads greater than 93,000 and 28,000 copies of HIV-1 viral RNA/mL respectively.

Approval Date: 11/19/2001

Product Information

Label - NucliSens HIV-1 QT

Supporting Documents

Supporting Documents older than three years - NucliSens HIV-1 QT

Resources For You

Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents

Top