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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448