DevicePMAs@therightstef:P100032_S007 JSONTXT

{"project":"PMA_MER","denotations":[{"id":"T1","span":{"begin":0,"end":8},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25425"},{"id":"T2","span":{"begin":17,"end":26},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C50651"},{"id":"T3","span":{"begin":250,"end":254},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42614"},{"id":"T4","span":{"begin":459,"end":464},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25304"},{"id":"T5","span":{"begin":479,"end":488},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T6","span":{"begin":491,"end":495},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T7","span":{"begin":496,"end":503},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T8","span":{"begin":518,"end":523},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14225"},{"id":"T9","span":{"begin":524,"end":529},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T10","span":{"begin":534,"end":540},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13356"},{"id":"T11","span":{"begin":542,"end":549},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C95186"},{"id":"T12","span":{"begin":559,"end":565},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C830"},{"id":"T13","span":{"begin":587,"end":592},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17600"},{"id":"T14","span":{"begin":623,"end":632},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T15","span":{"begin":640,"end":643},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"},{"id":"T16","span":{"begin":650,"end":654},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17102"},{"id":"T17","span":{"begin":659,"end":668},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T18","span":{"begin":692,"end":701},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T19","span":{"begin":705,"end":710},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25304"},{"id":"T20","span":{"begin":739,"end":749},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37984"},{"id":"T21","span":{"begin":750,"end":759},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15220"},{"id":"T22","span":{"begin":791,"end":802},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41264"},{"id":"T23","span":{"begin":810,"end":817},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15336"},{"id":"T24","span":{"begin":903,"end":914},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25361"},{"id":"T25","span":{"begin":928,"end":939},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71155"},{"id":"T26","span":{"begin":948,"end":958},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61256"},{"id":"T27","span":{"begin":991,"end":1015},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C111193"},{"id":"T28","span":{"begin":991,"end":1027},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C111194"},{"id":"T29","span":{"begin":1052,"end":1055},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T30","span":{"begin":1191,"end":1198},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25283"},{"id":"T31","span":{"begin":1191,"end":1206},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15311"},{"id":"T32","span":{"begin":1199,"end":1206},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61299"}],"text":"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."}