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Premarket Approval Information - Devices

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Applicant: MedMira Laboratories, Inc, CANADA
Product: MedMira Reveal Rapid HIV-1 Antibody Test
PMA number: BP000023/0
Indication for Use: Detection of antibodies to HIV-1 in human serum or plasma specimens
Approval Date: 4/16/2003

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Letter - (Text)

Label - (PDF)

Summary of Safety and Effectiveness - (Text)

 

Updated December 4, 2003
 
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