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Vaccines, Blood & Biologics
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
Letter - (Text)
Label - (PDF)
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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
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