FDA POSTS INFORMATION ON NEWLY APPROVED HCV DIAGNOSTIC TESTS
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).