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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
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)

 

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