FDAnews Device Daily Bulletin

FDA POSTS INFORMATION ON NEWLY APPROVED HCV DIAGNOSTIC TESTS

July 5, 2006
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The FDA June 30 posted information on the Architect Anti-HCV, Anti-HCV Calibrator and Anti-HCV Controls diagnostic tests approved June 7.

The tests, manufactured by Abbott Laboratories, are used to detect the Hepatitis C virus (HCV).

The FDA notice can be seen at www.fda.gov/cdrh/mda/docs/p050042.html (http://www.fda.gov/cdrh/mda/docs/p050042.html). The approval letter can be seen at www.fda.gov/cdrh/pdf5/p050042a.pdf (http://www.fda.gov/cdrh/pdf5/p050042a.pdf).