[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LLM":3},{"classification":4,"mappedDevices":67,"similarCandidates":68,"relatedClassifications":140,"syncDates":167},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":8,"definition":12,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":61,"updated_at":62,"recall_count":63,"latest_recall_date":64,"k510_count":65,"pma_count":66,"event_count":66},5487,"LLM","Test, Antigen, Nuclear, Epstein-Barr Virus","1","866.3235","MI","Microbiology","",false,{"openfda":15,"definition":12,"device_name":7,"review_code":12,"device_class":8,"implant_flag":58,"product_code":6,"review_panel":10,"gmp_exempt_flag":58,"third_party_flag":59,"medical_specialty":10,"regulation_number":9,"submission_type_id":8,"unclassified_reason":12,"life_sustain_support_flag":58,"medical_specialty_description":11,"summary_malfunction_reporting":60},{"k_number":16,"fei_number":44,"registration_number":54},[17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"K930002","K233605","K951822","K984133","K894626","K946158","K973941","K895708","K932742","K880043","K875203","K871298","K891542","K840417","K895707","K925690","K935730","K883600","K883601","K911473","K911569","K040120","K882440","K946353","K980598","K875170","K951549",[45,46,47,48,49,50,51,52,53],"3022178699","1318354","3002806557","1419968","3004036192","3002808212","2242436","1000306617","2918768",[45,46,55,56,48,49,51,57,53],"9610240","9610746","2029372","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",1,null,27,0,[],[69,77,85,92,99,106,113,120,127,134],{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":66,"vector_similarity":75,"score":76},1820,"尖叉試験・ワクチン用針","Ⅱ","15679022",0.127273,0.6067,0.0310993,{"medical_device_id":78,"generic_name":79,"class_classification":80,"jmdn_code":81,"name_similarity":82,"definition_similarity":66,"vector_similarity":83,"score":84},3399,"両眼視機能検査装置","Ⅰ","37071000",0.155172,0.573426,0.0302135,{"medical_device_id":86,"generic_name":87,"class_classification":72,"jmdn_code":88,"name_similarity":89,"definition_similarity":66,"vector_similarity":90,"score":91},1286,"甲状腺摂取率測定用核医学装置","40648000",0.126582,0.579342,0.0287904,{"medical_device_id":93,"generic_name":94,"class_classification":80,"jmdn_code":95,"name_similarity":96,"definition_similarity":66,"vector_similarity":97,"score":98},3596,"再使用可能な尖叉試験用針","15679001",0.103448,0.567546,0.025098,{"medical_device_id":100,"generic_name":101,"class_classification":72,"jmdn_code":102,"name_similarity":103,"definition_similarity":66,"vector_similarity":104,"score":105},1285,"核医学装置用手持型検出器","40646000",0.119403,0.554896,0.0250078,{"medical_device_id":107,"generic_name":108,"class_classification":72,"jmdn_code":109,"name_similarity":110,"definition_similarity":66,"vector_similarity":111,"score":112},1819,"単回使用尖叉試験用針","15679012",0.1,0.55837,0.0234311,{"medical_device_id":114,"generic_name":115,"class_classification":72,"jmdn_code":116,"name_similarity":117,"definition_similarity":66,"vector_similarity":118,"score":119},1279,"核医学診断用リング型SPECT装置","40643000",0.169231,0.538978,0.0163934,{"medical_device_id":121,"generic_name":122,"class_classification":72,"jmdn_code":123,"name_similarity":124,"definition_similarity":66,"vector_similarity":125,"score":126},1808,"健康検診システム","70178000",0.0724638,0.601293,0.016129,{"medical_device_id":128,"generic_name":129,"class_classification":72,"jmdn_code":130,"name_similarity":131,"definition_similarity":66,"vector_similarity":132,"score":133},1283,"RI動態機能検査装置","70008000",0.0875,0.594226,0.015873,{"medical_device_id":135,"generic_name":136,"class_classification":72,"jmdn_code":137,"name_similarity":138,"definition_similarity":66,"vector_similarity":139,"score":133},3109,"核医学診断用リング型SPECT装置用プログラム","40643012",0.142857,0.531175,[141,145,149,153,157,161,164],{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"LSE","Epstein-Barr Virus, Other",56,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"LJN","Antibody Igm, If, Epstein-Barr Virus",23,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"GNP","Antiserum, Cf, Epstein-Barr Virus",20,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"JRY","Antiserum, Fluorescent, Epstein-Barr Virus",9,{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"MCD","Antigen, Ebv, Capsid",8,{"product_code":162,"device_name":163,"device_class":8,"k510_count":66},"GNQ","Antigen, Cf (Including Cf Control), Epstein-Barr Virus",{"product_code":165,"device_name":166,"device_class":8,"k510_count":66},"LSF","Dna-Reagents, Epstein-Barr Virus",{"510k":168,"classification":169,"enforcement":170,"event":171,"pma":172,"warning_letter":173},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]