Recent Device Approvals: Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg - P130015

The U.S. Food and Drug Administration has recently approved the Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAgElecsys HBeAg Immunoassay to be marketed. The Elecsys HBeAg Immunoassay is a laboratory test used to detect human hepatitis B e antigen associated with the hepatitis B virus (HBV) infection. The Elecsys PreciControl HBeAg is used as a quality control to ensure that the test is working properly.  For more information, please see http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm391096.htm


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