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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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MedMira Reveal G2 Rapid HIV-1 Antibody Test

Applicant: MedMira Labs, CANADA
MedMira Reveal G2 Rapid HIV-1 Antibody Test
PMA number:
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:

Letter - (Text)

Label - (PDF)


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002