New Device Approval - COBAS TaqMan HCV Test For Use With the COBAS AmpliPrep Instrument and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer - P060030
MedSun: Newsletter #32, January 2009
FDA Center for Devices and Radiological Health (CDRH) Consumer Health Information Website
FDA has recently approved the COBAS TaqMan HCV Test. This laboratory test measures the amount of hepatitis C viral RNA in a patient's blood and is used to evaluate the treatment of an individual infected with the hepatitis C virus.
COBAS TaqMan HCV Test. FDA Center for Devices and Radiological Health (CDRH) Consumer Health Information Website. October 30, 2008.