[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LOO":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":107,"syncDates":131},{"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":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":35},300,"LOO","Reagent, Leishmanii Serological","1","866.3870","MI","Microbiology","",false,{"openfda":15,"definition":12,"device_name":7,"review_code":12,"device_class":8,"implant_flag":30,"product_code":6,"review_panel":10,"gmp_exempt_flag":30,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":8,"unclassified_reason":12,"life_sustain_support_flag":30,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":16,"fei_number":19,"registration_number":27},[17,18],"K842526","K023483",[20,21,22,23,24,25,26],"3026241718","3022178699","3017013438","3011527950","3003952975","3011561946","3002606748",[20,21,22,28,23,29,25],"2032682","3032562","N","Y","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,[],[40,48,54,62,68,76,82,89,95,102],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":35,"vector_similarity":46,"score":47},3509,"移動式免疫比濁分析装置","Ⅰ","35926020",0.0151515,0.617944,0.0163934,{"medical_device_id":49,"generic_name":50,"class_classification":43,"jmdn_code":51,"name_similarity":52,"definition_similarity":35,"vector_similarity":53,"score":47},4275,"泌尿器科用開創器","35311000",0.238095,0.530681,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":35,"vector_similarity":60,"score":61},2367,"泌尿器用ステント位置補正カテーテル","Ⅱ","70492000",0.224138,0.409639,0.016129,{"medical_device_id":63,"generic_name":64,"class_classification":43,"jmdn_code":65,"name_similarity":66,"definition_similarity":35,"vector_similarity":67,"score":61},3508,"免疫比濁分析装置","35926010",0.0169492,0.612151,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":35,"vector_similarity":74,"score":75},380,"長期的使用泌尿器用フォーリーカテーテル","Ⅲ","34917003",0.203125,0.431326,0.015873,{"medical_device_id":77,"generic_name":78,"class_classification":43,"jmdn_code":79,"name_similarity":80,"definition_similarity":35,"vector_similarity":81,"score":75},3514,"粒子計測免疫測定装置","70181000",0.0144928,0.599742,{"medical_device_id":83,"generic_name":84,"class_classification":71,"jmdn_code":85,"name_similarity":86,"definition_similarity":35,"vector_similarity":87,"score":88},1166,"マラリア診断装置","71081003",0.0178571,0.592345,0.015625,{"medical_device_id":90,"generic_name":91,"class_classification":43,"jmdn_code":92,"name_similarity":93,"definition_similarity":35,"vector_similarity":94,"score":88},3880,"泌尿器科用診察台","13969000",0.2,0.45496,{"medical_device_id":96,"generic_name":97,"class_classification":43,"jmdn_code":98,"name_similarity":99,"definition_similarity":35,"vector_similarity":100,"score":101},3510,"免疫蛍光分析装置","35707010",0.0545455,0.566516,0.0153846,{"medical_device_id":103,"generic_name":104,"class_classification":43,"jmdn_code":105,"name_similarity":93,"definition_similarity":35,"vector_similarity":106,"score":101},3564,"血球分離装置","15113000",0.495649,[108,112,116,119,122,125,128],{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"MIU","Enzyme Linked Immunosorbent Assay, T. Cruzi",6,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"GNE","Antigen, Latex Agglutination, T. Cruzi",1,{"product_code":117,"device_name":118,"device_class":8,"k510_count":115},"OUZ","Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids",{"product_code":120,"device_name":121,"device_class":8,"k510_count":115},"PIT","Leishmania Spp. Antigen Detection Assay",{"product_code":123,"device_name":124,"device_class":8,"k510_count":35},"GND","Antigen, Iha, T. Cruzi",{"product_code":126,"device_name":127,"device_class":8,"k510_count":35},"GNF","Antigen, Cf, T. Cruzi",{"product_code":129,"device_name":130,"device_class":8,"k510_count":35},"MIV","Immunofluorescent Assay, T. Cruzi",{"510k":132,"classification":133,"enforcement":134,"event":135,"pma":136,"warning_letter":137},"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"]