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Premarket Approval Information - Devices

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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

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Letter - (Text)

Label - (PDF)

 

Updated June 25, 2004
 
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