DevicePMAs@therightstef:P130015_S000 JSONTXT 11 Projects

Approval for the elecsys hbeag immunoassay and elecsys precicontrol hbeag. this device is indicated for: elecsys hbeag immunoassaythe elecsys hbeag immunoassay is intended for the in vitro qualitative determination of hepatitis b e antigen (hbeag) in human serum or plasma (k2-edta, lithium or sodium heparin, and sodium citrate) in adult patients with symptoms of hepatitis or at risk for hepatitis b virus (hbv) infection. the assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b or recovery from hepatitis b infection. The electrochemilumin-escence immunoassay eclia is intended for use on the modular analytics e170 analyzer. elecsys precicontrol hbeag elecsys precicontrol hbeag is used for quality control of the elecsys hbeag immunoassay on the modular analytics e170 analyzer.