FDAnews Device Daily Bulletin

FDA APPROVES BAYER DIAGNOSTICS' FULLY AUTOMATED HIV ANTIBODY TEST

June 23, 2006
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Bayer HealthCare's diagnostics division has announced that the FDA has approved its fully automated test to detect antibodies for three strains of HIV.

The ADVIA Centaur Immunoassay System is an in vitro EHIV (human immunodeficiency virus, enhanced) test to detect antibodies for HIV 1, HIV 2 and HIV 1 sub-type O in human serum and plasma, Bayer said.

The ADVIA Centaur diagnostic is currently the only fully automated test available to detect this particular strain of HIV, the company said.