DevicePMAs@therightstef:P990038_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":41,"end":46},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T3","span":{"begin":53,"end":59},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T4","span":{"begin":108,"end":114},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16554"},{"id":"T5","span":{"begin":108,"end":126},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17455"},{"id":"T6","span":{"begin":146,"end":149},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T7","span":{"begin":186,"end":195},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T8","span":{"begin":198,"end":205},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25245"},{"id":"T9","span":{"begin":206,"end":213},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C268"},{"id":"T10","span":{"begin":225,"end":230},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14225"},{"id":"T11","span":{"begin":231,"end":236},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13325"},{"id":"T12","span":{"begin":240,"end":246},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13356"},{"id":"T13","span":{"begin":254,"end":261},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C63374"},{"id":"T14","span":{"begin":265,"end":272},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C539"},{"id":"T15","span":{"begin":311,"end":317},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62612"},{"id":"T16","span":{"begin":318,"end":321},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T17","span":{"begin":401,"end":410},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T18","span":{"begin":439,"end":449},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37984"},{"id":"T19","span":{"begin":450,"end":459},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15220"},{"id":"T20","span":{"begin":464,"end":473},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C3095"},{"id":"T21","span":{"begin":464,"end":481},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14215"},{"id":"T22","span":{"begin":476,"end":481},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14283"},{"id":"T23","span":{"begin":506,"end":511},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14140"},{"id":"T24","span":{"begin":537,"end":548},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41264"},{"id":"T25","span":{"begin":556,"end":563},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15336"},{"id":"T26","span":{"begin":634,"end":639},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T27","span":{"begin":642,"end":653},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25361"},{"id":"T28","span":{"begin":667,"end":678},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71155"},{"id":"T29","span":{"begin":687,"end":697},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61256"},{"id":"T30","span":{"begin":731,"end":736},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T31","span":{"begin":771,"end":780},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48261"},{"id":"T32","span":{"begin":784,"end":789},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12434"},{"id":"T33","span":{"begin":793,"end":799},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C13356"}],"text":"Approval for the diasorin eti-mak-2 plus assay. The device is indicated for: eti-mak-2 plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative determination of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, citrate or heparin). The eti-mak-2 plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of hbsag is indicative of a laboratory diagnosis for hepatitis b virus (hbv) infection, either acute or chronic. Further hbv serological marker testing is required to define the specific disease state. The eti-mak-2 plus assay's performance has not been established for the monitoring of hbv disease or therapy. This assay has not been fda-approved for the screening of blood or plasma donors."}