DevicePMAs@therightstef:P100001_S000 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":59,"end":66},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C802"},{"id":"T3","span":{"begin":103,"end":109},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T4","span":{"begin":170,"end":177},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C802"},{"id":"T5","span":{"begin":212,"end":221},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T6","span":{"begin":239,"end":248},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T7","span":{"begin":253,"end":260},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T8","span":{"begin":275,"end":280},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14225"},{"id":"T9","span":{"begin":281,"end":286},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17600"},{"id":"T10","span":{"begin":291,"end":300},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14154"},{"id":"T11","span":{"begin":316,"end":319},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C65010"},{"id":"T12","span":{"begin":321,"end":326},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T13","span":{"begin":365,"end":372},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14141"},{"id":"T14","span":{"begin":365,"end":382},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C82978"},{"id":"T15","span":{"begin":373,"end":382},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T16","span":{"begin":421,"end":430},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C128320"},{"id":"T17","span":{"begin":492,"end":502},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25217"},{"id":"T18","span":{"begin":510,"end":519},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C128320"},{"id":"T19","span":{"begin":534,"end":545},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41264"},{"id":"T20","span":{"begin":561,"end":565},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48057"},{"id":"T21","span":{"begin":566,"end":573},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15336"},{"id":"T22","span":{"begin":642,"end":646},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C47891"},{"id":"T23","span":{"begin":647,"end":658},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25361"},{"id":"T24","span":{"begin":672,"end":683},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71155"},{"id":"T25","span":{"begin":692,"end":702},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61256"},{"id":"T26","span":{"begin":789,"end":792},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T27","span":{"begin":800,"end":811},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C69187"},{"id":"T28","span":{"begin":895,"end":899},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C47891"},{"id":"T29","span":{"begin":929,"end":938},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T30","span":{"begin":956,"end":965},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T31","span":{"begin":970,"end":977},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T32","span":{"begin":1046,"end":1049},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T33","span":{"begin":1053,"end":1063},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61256"},{"id":"T34","span":{"begin":1068,"end":1079},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25361"},{"id":"T35","span":{"begin":1103,"end":1107},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C47891"}],"text":"Approval for the vitros immunodiagnostic products anti-hbe reagent pack, calibrator and controls. this device is indicated for: vitros immunodiagnostic products anti-hbe reagent pack for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from hbv infection, using the vitros eci/eciq immunodiagnostic systems. further assessment of hbv infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. Vitros anti-hbe test performance has not been established for the monitoring of hbv disease or therapy. Vitros immunodiagnostic products anti-hbe calibrator for use in the calibration of the vitros eci/eciq immunodiagnostic systems when used with the vitros anti-hbe test for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe). Vitros immunodiagnostic products anti-hbe controls for use in monitoring the performance of the vitros anti-hbe test when used on the vitros eci/eciq immunodiagnostic systems."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":281,"end":286},"obj":"age_category"},{"id":"T2","span":{"begin":291,"end":300},"obj":"age_category"},{"id":"T3","span":{"begin":302,"end":303},"obj":"age_start"},{"id":"T4","span":{"begin":307,"end":309},"obj":"age_end"},{"id":"T5","span":{"begin":310,"end":315},"obj":"age_end_unit"},{"id":"T6","span":{"begin":302,"end":319},"obj":"age_range"}],"text":"Approval for the vitros immunodiagnostic products anti-hbe reagent pack, calibrator and controls. this device is indicated for: vitros immunodiagnostic products anti-hbe reagent pack for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from hbv infection, using the vitros eci/eciq immunodiagnostic systems. further assessment of hbv infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. Vitros anti-hbe test performance has not been established for the monitoring of hbv disease or therapy. Vitros immunodiagnostic products anti-hbe calibrator for use in the calibration of the vitros eci/eciq immunodiagnostic systems when used with the vitros anti-hbe test for the in vitro qualitative detection of antibodies to hepatitis b e antigen (anti-hbe). Vitros immunodiagnostic products anti-hbe controls for use in monitoring the performance of the vitros anti-hbe test when used on the vitros eci/eciq immunodiagnostic systems."}