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Reuters Health Information (2005-01-18): Bayer gets US FDA approval for hepatitis C test Regulatory
Bayer gets US FDA approval for hepatitis C test
Last Updated: 2005-01-18 15:38:12 -0400 (Reuters Health)
FRANKFURT (Reuters) - Bayer AG has received approval
from the U.S. Food and Drug Administration for its automated assay for
hepatitis C virus (HCV), the German drugs and chemicals group said in a
statement on Tuesday.
The HCV assay is manufactured and sold by Bayer Diagnostics for
Ortho-Clinical Diagnostics, a subsidiary of Johnson & Johnson,
Bayer said. The product is based on technology from Chiron Corp.
"We are currently working on a quick market launch for the product in the United States," a Bayer spokeswoman said.
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