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Approval for the migration of claims from the fda approved elecsys anti-hbc immunoassay and elecsys precicontrol anti-hbc on the elecsys 2010 analyzer to the cobas e 411 immunoassay analyzer. the device, as modified, will be marketed under the trade name elecsys anti-hbc immunoassay and elecsys precicontrol anti-hbc and is indicated for: elecsys anti-hbc immunoassaythe elecsys anti-hbc immunoassay is intended 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 of hbv disease or therapy. The electrochemiluminescence immunoassay "eclia" is intended for use on the elecsys 2010 and the cobas e 411 immunoassay analyzers. elecsys precicontrol anti-hbc elecsys precicontro1 anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the elecsys 2010 and the cobas e411 immunoassay analyzers.
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