DevicePMAs@therightstef:P100001_S000 JSONTXT 11 Projects

Approval for the vitros immunodiagnostic products anti-hbe reagent pack, calibrator and controls. this device is indicated for: vitros immunodiagnostic products anti-hbe reagent pack for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from hbv infection, using the vitros eci/eciq immunodiagnostic systems. further assessment of hbv infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. Vitros anti-hbe test performance has not been established for the monitoring of hbv disease or therapy. Vitros immunodiagnostic products anti-hbe calibrator for use in the calibration of the vitros eci/eciq immunodiagnostic systems when used with the vitros anti-hbe test for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe). Vitros immunodiagnostic products anti-hbe controls for use in monitoring the performance of the vitros anti-hbe test when used on the vitros eci/eciq immunodiagnostic systems.