DevicePMAs@therightstef:P080023_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":27,"end":31},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T3","span":{"begin":32,"end":39},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C802"},{"id":"T4","span":{"begin":55,"end":59},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T5","span":{"begin":85,"end":89},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T6","span":{"begin":144,"end":148},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T7","span":{"begin":149,"end":156},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C802"},{"id":"T8","span":{"begin":176,"end":180},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T9","span":{"begin":181,"end":186},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T10","span":{"begin":209,"end":222},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C120025"},{"id":"T11","span":{"begin":261,"end":270},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T12","span":{"begin":274,"end":277},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C568"},{"id":"T13","span":{"begin":282,"end":285},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C569"},{"id":"T14","span":{"begin":300,"end":309},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T15","span":{"begin":338,"end":343},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14225"},{"id":"T16","span":{"begin":344,"end":349},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17600"},{"id":"T17","span":{"begin":354,"end":363},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14154"},{"id":"T18","span":{"begin":364,"end":369},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T19","span":{"begin":374,"end":380},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13356"},{"id":"T20","span":{"begin":407,"end":414},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C539"},{"id":"T21","span":{"begin":416,"end":422},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C830"},{"id":"T22","span":{"begin":423,"end":430},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C539"},{"id":"T23","span":{"begin":445,"end":450},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T24","span":{"begin":484,"end":493},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15220"},{"id":"T25","span":{"begin":525,"end":534},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T26","span":{"begin":525,"end":542},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14215"},{"id":"T27","span":{"begin":537,"end":542},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14283"},{"id":"T28","span":{"begin":549,"end":558},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C128320"},{"id":"T29","span":{"begin":562,"end":573},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C79874"},{"id":"T30","span":{"begin":585,"end":595},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37984"},{"id":"T31","span":{"begin":608,"end":616},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25398"},{"id":"T32","span":{"begin":640,"end":644},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T33","span":{"begin":671,"end":675},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T34","span":{"begin":703,"end":714},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C69187"},{"id":"T35","span":{"begin":749,"end":755},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T36","span":{"begin":784,"end":793},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T37","span":{"begin":797,"end":800},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C568"},{"id":"T38","span":{"begin":805,"end":808},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C569"},{"id":"T39","span":{"begin":834,"end":838},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T40","span":{"begin":839,"end":846},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T41","span":{"begin":877,"end":881},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T42","span":{"begin":882,"end":889},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C802"},{"id":"T43","span":{"begin":899,"end":910},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25361"},{"id":"T44","span":{"begin":928,"end":932},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T45","span":{"begin":957,"end":968},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71155"},{"id":"T46","span":{"begin":1011,"end":1015},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T47","span":{"begin":1040,"end":1044},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T48","span":{"begin":1067,"end":1077},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61256"},{"id":"T49","span":{"begin":1082,"end":1093},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25361"},{"id":"T50","span":{"begin":1113,"end":1119},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T51","span":{"begin":1150,"end":1159},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T52","span":{"begin":1163,"end":1166},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C568"},{"id":"T53","span":{"begin":1171,"end":1174},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C569"},{"id":"T54","span":{"begin":1189,"end":1198},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T55","span":{"begin":1201,"end":1205},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T56","span":{"begin":1206,"end":1213},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T57","span":{"begin":1244,"end":1248},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T58","span":{"begin":1249,"end":1256},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C802"},{"id":"T59","span":{"begin":1294,"end":1298},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25327"},{"id":"T60","span":{"begin":1321,"end":1332},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71155"}],"text":"Approval for the architect core reagent kit, architect core calibrator and architect core controls. These devices are indicated for: architect core reagent kit: the architect core assay is a chemiluminescent microparticle immunoassay(cmia) for the qualitative detection of igg and igm antibodies to hepatitis b coreantigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta,lithium heparin, sodium heparin) and neonatal serum. it is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. architect core calibrator: the architect core calibrator is used for the calibration of the architect isystem when the system is used for the qualitative detection of igg and igm antibodies tohepatitis b core antigen (anti-hbc) with the architect core reagent kit. the performance of the architect core calibrator has not been established with any other anti-hbc assays. architect core controls: the architect core controls arc used for monitoring the performance of the architect i system when used for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) with the architect core reagent kit. theperformance of the architect core controls has not been established with any otheranti-hbc assays."}

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":344,"end":349},"obj":"age_category"},{"id":"T2","span":{"begin":354,"end":363},"obj":"age_category"},{"id":"T3","span":{"begin":436,"end":444},"obj":"age_category"}],"text":"Approval for the architect core reagent kit, architect core calibrator and architect core controls. These devices are indicated for: architect core reagent kit: the architect core assay is a chemiluminescent microparticle immunoassay(cmia) for the qualitative detection of igg and igm antibodies to hepatitis b coreantigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta,lithium heparin, sodium heparin) and neonatal serum. it is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. architect core calibrator: the architect core calibrator is used for the calibration of the architect isystem when the system is used for the qualitative detection of igg and igm antibodies tohepatitis b core antigen (anti-hbc) with the architect core reagent kit. the performance of the architect core calibrator has not been established with any other anti-hbc assays. architect core controls: the architect core controls arc used for monitoring the performance of the architect i system when used for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) with the architect core reagent kit. theperformance of the architect core controls has not been established with any otheranti-hbc assays."}

{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T1","span":{"begin":344,"end":349},"obj":"age_category"},{"id":"T2","span":{"begin":354,"end":363},"obj":"age_category"},{"id":"T3","span":{"begin":436,"end":444},"obj":"age_category"}],"text":"Approval for the architect core reagent kit, architect core calibrator and architect core controls. These devices are indicated for: architect core reagent kit: the architect core assay is a chemiluminescent microparticle immunoassay(cmia) for the qualitative detection of igg and igm antibodies to hepatitis b coreantigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta,lithium heparin, sodium heparin) and neonatal serum. it is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. architect core calibrator: the architect core calibrator is used for the calibration of the architect isystem when the system is used for the qualitative detection of igg and igm antibodies tohepatitis b core antigen (anti-hbc) with the architect core reagent kit. the performance of the architect core calibrator has not been established with any other anti-hbc assays. architect core controls: the architect core controls arc used for monitoring the performance of the architect i system when used for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) with the architect core reagent kit. theperformance of the architect core controls has not been established with any otheranti-hbc assays."}