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

MedMira Reveal G2 Rapid HIV-1 Antibody Test

Applicant: MedMira Labs, CANADA
Product: MedMira Reveal G2 Rapid HIV-1 Antibody Test
PMA number: BP000023/15
Indication for Use:

To allow for the addition of a procedural and reagent control line, a change in the packaging of the Colorimetric Detection Agent, and a change in the name of the device to Reveal TM G2 Rapid HIV-1 Antibody Test

Approval Date: 6/23/2004

Product Information

Package Insert - MedMira Reveal G2 Rapid HIV-1 Antibody Test

Supporting Documents

Supporting Documents older than three years - MedMira Reveal G2 Rapid HIV-1 Antibody Test

Top