-

Vaccines, Blood & Biologics

  • Share Share this page

ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents

Applicant: Bayer HealthCare
Product: ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
PMA number: BP050030 / 0
Indication for Use: For qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasma
Approval Date: 5/18/2006


Letter

Label (PDF - 377 KB)

Summary of Safety & Effectiveness (PDF - 349 KB)

    
 

Contact Us

  • Consumer Affairs Branch (CBER)

  • (800) 835-4709
  • (301) 827-1800
  • 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

-
-
-
-
-
-