DevicePMAs@therightstef:P100031_S000 JSONTXT 11 Projects

Approval for the elecsys anti-hbc immunoassay & elecsys precicontrol anti-hbc for use on the modular analytics e170 immunoassay analyzer. this device is indicated for the in vitro qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum and plasma (lithium-heparin, sodium-citrate, k2-edta) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis b (hbv) infection. the detection of total anti-hbc is indicative of a laboratory diagnosis for hbv infection. further hbv serological marker testing is required to define the specific disease state. the elecsys anti-hbc immunoassay's performance has not been established for the monitoring hbv disease or therapy. the electro- chemiluminescence immunoassay "eclia" is intended for use on the modular analytics ei70 immunoassay analyzer. the elecsys preci-control anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the modular analytics e170 immunoassay analyzer.