Hepatitis B Virus

Abbott receives U.S. FDA approval for automated blood screening tests for hepatitis B

Published in Medical Letter on the CDC and FDA, August 20th, 2006

Abbott (ABT) announced it received approval from the U.S. Food and Drug Administration for its Abbott Prism hepatitis B surface antigen (HBsAg) and its PRISM HBsAg Confirmatory test. These tests can be used by laboratory technicians to screen donated blood for HBsAg.

Used in more than 30 countries, the PRISM system was recently approved for use in the United States with its first hepatitis B test, PRISM HBcore, introduced in October. Additional hepatitis and retrovirus screening tests are currently under FDA review.

"We continue to focus on expanding our automated hepatitis testing menus across all of our diagnostic platforms," said Don Patton, vice...

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Source: Medical Letter on the CDC and FDA (2006-08-20)

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