DevicePMAs@therightstef:P110022_S000 / 34-37
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Approval for the elecsys anti-hbc igm immunoassay and elecsys precicontrol anti-hbc igm for use on the cobas e 601 immunoassay analyzer. this device is indicated for: the elecsys anti-hbc igm immunoassay is intended for the in vitro qualitative determination of igm antibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassium edta, lithium heparin. sodium heparin, sodium citrate) in adult patients with symptoms of hepatitis or who may be at risk for hepatitis b (1ibv) injection. the presence of anti-hbc igm. in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis b virus (hbv) infection. the elecsys anti-hbc igm immunoassay's performance has not been established for the monitoring of hbv disease or therapy. the electrochemilu-minescence immunoassay "eclia" is intended for use on the cobas e 601 immunoassay analyzer. precicontroi anti-hbc igm elecsys precicontrol anti-hbc igm is used for quality control of the elecsys anti-hbc igm immunoassay on the cobas e 601 immunoassay analyzer.
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