DevicePMAs@therightstef:P100031_S000 JSONTXT

{"project":"PMA_Manual","denotations":[{"id":"T1","span":{"begin":0,"end":137},"obj":"pma_purpose"},{"id":"T2","span":{"begin":138,"end":437},"obj":"main_indication"},{"id":"T3","span":{"begin":438,"end":528},"obj":"indication_context"},{"id":"T4","span":{"begin":529,"end":617},"obj":"indication_context"},{"id":"T5","span":{"begin":618,"end":732},"obj":"contraindication"},{"id":"T6","span":{"begin":733,"end":855},"obj":"component_detail"},{"id":"T7","span":{"begin":856,"end":1006},"obj":"component_detail"}],"text":"Approval for the elecsys anti-hbc immunoassay \u0026 elecsys precicontrol anti-hbc for use on the modular analytics e170 immunoassay analyzer. this device is indicated 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 hbv disease or therapy. the electro- chemiluminescence immunoassay \"eclia\" is intended for use on the modular analytics ei70 immunoassay analyzer. the elecsys preci-control anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the modular analytics e170 immunoassay analyzer."}

{"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":82,"end":85},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T3","span":{"begin":143,"end":149},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T4","span":{"begin":209,"end":214},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25304"},{"id":"T5","span":{"begin":229,"end":238},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T6","span":{"begin":241,"end":245},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T7","span":{"begin":246,"end":253},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T8","span":{"begin":268,"end":273},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14225"},{"id":"T9","span":{"begin":274,"end":279},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T10","span":{"begin":284,"end":290},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13356"},{"id":"T11","span":{"begin":337,"end":342},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17600"},{"id":"T12","span":{"begin":373,"end":382},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T13","span":{"begin":390,"end":393},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"},{"id":"T14","span":{"begin":400,"end":404},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17102"},{"id":"T15","span":{"begin":409,"end":418},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T16","span":{"begin":442,"end":451},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T17","span":{"begin":455,"end":460},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25304"},{"id":"T18","span":{"begin":489,"end":499},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37984"},{"id":"T19","span":{"begin":500,"end":509},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15220"},{"id":"T20","span":{"begin":541,"end":552},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41264"},{"id":"T21","span":{"begin":560,"end":567},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15336"},{"id":"T22","span":{"begin":653,"end":664},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25361"},{"id":"T23","span":{"begin":678,"end":689},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71155"},{"id":"T24","span":{"begin":698,"end":708},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61256"},{"id":"T25","span":{"begin":746,"end":763},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C123895"},{"id":"T26","span":{"begin":800,"end":803},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T27","span":{"begin":903,"end":910},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25283"},{"id":"T28","span":{"begin":903,"end":918},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15311"},{"id":"T29","span":{"begin":911,"end":918},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61299"}],"text":"Approval for the elecsys anti-hbc immunoassay \u0026 elecsys precicontrol anti-hbc for use on the modular analytics e170 immunoassay analyzer. this device is indicated 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 hbv disease or therapy. the electro- chemiluminescence immunoassay \"eclia\" is intended for use on the modular analytics ei70 immunoassay analyzer. the elecsys preci-control anti-hbc is used for quality control of the elecsys anti-hbc immunoassay on the modular analytics e170 immunoassay analyzer."}