DevicePMAs@therightstef:P990012_S000 JSONTXT 11 Projects

Approval for the elecsys. hbsag immunoassay, elecsys hbsag confirmatory, and precicontrol hbsag. The devices are indicated for: elecsys hbsag immunoassay is an immunoassay for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (heparin, edta-k3, sodium citrate). 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. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. The electrochemiluminescence immunoassay "eclia" is intended for use on the roche elecsys 2010 immunoassay system. Elecsys hbsag confirmatory is an immunoassay for the in vitro qualitative confirmation of the presence of hepatitis b surface antigen in human serum and plasma (heparin, edta-k3, sodium citrate) samples repeatedly reactive when tested with elecsys 2010 hbsag immunoassay. Precicontrol hbsag is used for quality control of the elecsys hbsag immunoassay on the elecsys 2010 immunoassay system when testing human serum. The performance of the precicontrol hbsag has not been established with any other hbsag assay.