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Vaccines, Blood & Biologics

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MedMira Reveal Rapid HIV-1 Antibody Test

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


Letter

Label (PDF - 191 KB)

Summary of Safety and Effectiveness

    
 

Contact Us

  • (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

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