[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NGS":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":105,"syncDates":110},{"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":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":31},906,"NGS","Assay, Endotoxin Activity, Chemiluminescent","2","866.3210","MI","Microbiology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":17,"fei_number":20,"registration_number":22},[18,19],"K183176","DEN030002",[21],"3000058367",[23],"9617857","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,8,[],[34,42,49,57,65,72,79,86,92,99],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":28,"vector_similarity":40,"score":41},3512,"免疫発光測定装置","Ⅰ","36223010",0.385965,0.707785,0.0327869,{"medical_device_id":43,"generic_name":44,"class_classification":37,"jmdn_code":45,"name_similarity":46,"definition_similarity":28,"vector_similarity":47,"score":48},3513,"移動式免疫発光測定装置","36223020",0.34375,0.69878,0.0322581,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":28,"vector_similarity":55,"score":56},755,"エンドトキシン除去向け吸着型血液浄化用装置","Ⅲ","35104020",0.153846,0.619296,0.030303,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":28,"vector_similarity":63,"score":64},2392,"エンドトキシン除去向け吸着型血液浄化用血液回路","Ⅱ","70554000",0.139535,0.611395,0.0287904,{"medical_device_id":66,"generic_name":67,"class_classification":52,"jmdn_code":68,"name_similarity":69,"definition_similarity":28,"vector_similarity":70,"score":71},750,"エンドトキシン除去向け吸着型血液浄化用浄化器","70535000",0.189189,0.584202,0.028373,{"medical_device_id":73,"generic_name":74,"class_classification":37,"jmdn_code":75,"name_similarity":76,"definition_similarity":28,"vector_similarity":77,"score":78},3536,"微生物由来成分分析装置","70183000",0.0606061,0.663388,0.015873,{"medical_device_id":80,"generic_name":81,"class_classification":60,"jmdn_code":82,"name_similarity":83,"definition_similarity":28,"vector_similarity":84,"score":85},1459,"マップ脳波計","11467020",0.188406,0.501083,0.015625,{"medical_device_id":87,"generic_name":88,"class_classification":37,"jmdn_code":89,"name_similarity":90,"definition_similarity":28,"vector_similarity":91,"score":85},3510,"免疫蛍光分析装置","35707010",0.0967742,0.643442,{"medical_device_id":93,"generic_name":94,"class_classification":37,"jmdn_code":95,"name_similarity":96,"definition_similarity":28,"vector_similarity":97,"score":98},3320,"熱ルミネセンス線量計用コンパクト電位計","37110000",0.171053,0.495883,0.0153846,{"medical_device_id":100,"generic_name":101,"class_classification":37,"jmdn_code":102,"name_similarity":103,"definition_similarity":28,"vector_similarity":104,"score":98},3511,"移動式免疫蛍光分析装置","35707020",0.0869565,0.633737,[106],{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"NTM","Antigen, Inflammatory Response Marker, Sepsis",3,{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"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","2026-08-18T06:42:29.411+00:00"]