[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OSU":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":114,"syncDates":118,"translation":125,"marketSummary":132,"recalls":145,"k510s":147,"pmas":154},{"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":32,"updated_at":33,"recall_count":34,"latest_recall_date":35,"k510_count":36,"pma_count":34,"event_count":34},744,"OSU","Dengue Serological Reagents","2","866.3945","MI","Microbiology","1","Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue  virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":29,"device_class":8,"implant_flag":30,"product_code":6,"review_panel":10,"gmp_exempt_flag":30,"third_party_flag":30,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":29,"life_sustain_support_flag":30,"medical_specialty_description":11,"summary_malfunction_reporting":31},{"k_number":17,"fei_number":19,"registration_number":26},[18],"DEN100020",[20,21,22,23,24,25],"2431980","3026565854","2023365","3024756665","1000306617","3002606748",[20,21,27,22,23,28],"3032562","2029372","","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:49.169481+00:00",0,null,1,[],[39,48,55,63,70,77,84,93,100,108],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},3510,"免疫蛍光分析装置","Ⅰ","35707010",0.0377358,0.253731,0.694394,0.0163934,{"medical_device_id":49,"generic_name":50,"class_classification":42,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":47},4275,"泌尿器科用開創器","35311000",0.25641,0.180791,0.501497,{"medical_device_id":56,"generic_name":57,"class_classification":42,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},3511,"移動式免疫蛍光分析装置","35707020",0.0333333,0.253776,0.692217,0.016129,{"medical_device_id":64,"generic_name":65,"class_classification":42,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":62},3564,"血球分離装置","15113000",0.214286,0.255132,0.547719,{"medical_device_id":71,"generic_name":72,"class_classification":42,"jmdn_code":73,"name_similarity":62,"definition_similarity":74,"vector_similarity":75,"score":76},3506,"移動式酵素免疫測定装置","35706020",0.23,0.65023,0.015873,{"medical_device_id":78,"generic_name":79,"class_classification":42,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":76},3880,"泌尿器科用診察台","13969000",0.216216,0.206497,0.493559,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1166,"マラリア診断装置","Ⅲ","71081003",0.0384615,0.24359,0.649235,0.015625,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":67,"definition_similarity":98,"vector_similarity":99,"score":92},2367,"泌尿器用ステント位置補正カテーテル","Ⅱ","70492000",0.122677,0.441885,{"medical_device_id":101,"generic_name":102,"class_classification":87,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},383,"瘻排液向け泌尿器用カテーテル","31074009",0.211538,0.115242,0.416327,0.0153846,{"medical_device_id":109,"generic_name":110,"class_classification":42,"jmdn_code":111,"name_similarity":76,"definition_similarity":112,"vector_similarity":113,"score":107},3509,"移動式免疫比濁分析装置","35926020",0.247126,0.64698,[115],{"product_code":116,"device_name":117,"device_class":8,"k510_count":36},"QCU","Dengue Virus Antigen Assay",{"510k":119,"classification":120,"enforcement":121,"event":122,"pma":123,"warning_letter":124},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":126,"definition_ja":127,"commentary_ja":128,"model_name":129,"source_hash":130,"reviewed_by":35,"reviewed_at":35,"created_at":131,"updated_at":131},"デング熱血清学的試薬","デングウイルス血清学的試薬は、デング熱に一致する徴候及び症状を有する個人における抗デング抗体の検出のための抗原及び抗血清からなる機器である。この検出は、デングウイルスによって引き起こされるデング熱又はデング出血熱の臨床検査診断を補助する。本機器は、他の臨床所見及び検査所見と併せて、患者の推定診断に用いることを意図している。","本機器は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象として、既存の同等品との実質的同等性を示すことで販売が認められる区分に位置づけられています。クラスIIは中程度のリスクを有する医療機器を対象とし、性能規格や特別な管理措置によって安全性及び有効性が確保される区分です。","claude-sonnet-5","a9c0b7f66a638b23840d829e21d2bbacc09aafcd76e82494c5bcfedb9956b618","2026-08-24T02:26:34.466715+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":143,"model_name":129,"created_at":144,"updated_at":144},"510(k)の累計件数は1件で、参入企業数は1社にとどまり、直近5年の届出実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、報告や事例は確認されていません。",{"pma":135,"k510":136,"as_of":138,"events":139,"recalls":140,"top_problems":142},{"latest":35,"originals":34,"supplements":34},{"total":36,"last5y":34,"latest":137,"applicants":36},"2011-04-08","2026-08",{"death":34,"other":34,"total":34,"injury":34,"last5y":34,"malfunction":34,"latest_month":35},{"total":34,"last5y":34,"latest":35,"class_i":34,"class_ii":34,"class_iii":34,"top_root_causes":141},[],[],"8aea152cd0b5df0919bf12d21a682067acfea83261b416ca25fd1bfda1616c53","2026-08-24T05:07:49.137996+00:00",{"items":146,"total":34},[],{"items":148,"total":36},[149],{"k_number":18,"device_name":150,"applicant":151,"decision_date":137,"clearance_type":152,"decision_code":153,"statement_or_summary":35},"DENV DETECT IGM CAPTURE ELISA","Inbios Intl., Inc.","Post-NSE","DENG",{"items":155,"total":34},[]]