Premarket Approval Information - Devices
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