[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QCU":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":122,"syncDates":126,"translation":133,"marketSummary":140,"recalls":153,"k510s":155,"pmas":163},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":37},3599,"QCU","Dengue Virus Antigen Assay","2","866.3945","MI","Microbiology","1","Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection",false,{"openfda":16,"definition":13,"device_name":7,"review_code":32,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":32,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":17,"fei_number":19,"registration_number":28},[18],"K181473",[20,21,22,23,24,25,26,27],"3017013438","3003952975","3024753119","3011561946","3002800697","2245285","1000306617","3002606748",[29,20,30,31,22,23,24,25],"2029372","2032682","3032562","","N","Ineligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:48.758894+00:00",0,null,1,[],[42,51,59,67,75,83,91,100,107,115],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},3555,"ラジオイムノアッセイ用装置","Ⅰ","35506000",0.130435,0.162162,0.612858,0.0308349,{"medical_device_id":52,"generic_name":53,"class_classification":45,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},3505,"酵素免疫測定装置","35706010",0.125,0.15812,0.61777,0.03031,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},3514,"粒子計測免疫測定装置","70181000",0.12069,0.101942,0.646009,0.0300179,{"medical_device_id":68,"generic_name":69,"class_classification":45,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},3506,"移動式酵素免疫測定装置","35706020",0.109091,0.157205,0.619539,0.0284848,{"medical_device_id":76,"generic_name":77,"class_classification":45,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},3503,"デンシトメトリー分析装置","15129000",0.116279,0.16188,0.596927,0.0278638,{"medical_device_id":84,"generic_name":85,"class_classification":45,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},3512,"免疫発光測定装置","36223010",0.103448,0.149254,0.593881,0.0254787,{"medical_device_id":92,"generic_name":93,"class_classification":94,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},1262,"アナログ式歯科用パノラマX線診断装置","Ⅱ","37637000",0.140351,0.12844,0.485252,0.0163934,{"medical_device_id":101,"generic_name":102,"class_classification":45,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":99},3511,"移動式免疫蛍光分析装置","35707020",0.0344828,0.200772,0.646869,{"medical_device_id":108,"generic_name":109,"class_classification":45,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},3510,"免疫蛍光分析装置","35707010",0.0392157,0.19697,0.645191,0.015873,{"medical_device_id":116,"generic_name":117,"class_classification":45,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":114},4241,"舌圧子","14066000",0.131579,0.152174,0.40552,[123],{"product_code":124,"device_name":125,"device_class":8,"k510_count":39},"OSU","Dengue Serological Reagents",{"510k":127,"classification":128,"enforcement":129,"event":130,"pma":131,"warning_letter":132},"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":134,"definition_ja":135,"commentary_ja":136,"model_name":137,"source_hash":138,"reviewed_by":38,"reviewed_at":38,"created_at":139,"updated_at":139},"デングウイルス抗原検出試薬","デングウイルス感染症に一致する徴候および症状を有するヒト患者から採取されたヒト血清または血漿中のデングウイルス抗原を定性的に検出するものである。","本品は米国では規制上クラスIIに分類されており、市販前届出（510(k)）の対象となっています。これは、市販前承認（PMA）を要するクラスIIIの機器と比較して相対的にリスクが低く、既存の同等な機器との実質的同等性を示すことで市販が可能となる区分です。","claude-sonnet-5","368d70f5b99fc8903c82781f9975cd1b5627b8769e7579621dd6b285d78153e4","2026-08-24T02:35:22.423427+00:00",{"product_code":6,"summary_ja":141,"stats":142,"stats_hash":151,"model_name":137,"created_at":152,"updated_at":152},"QCU（Dengue Virus Antigen Assay）は510(k)による届出品目で、累計1件が2018年8月に判定を受けており、参入企業数は1社にとどまります。直近5年間の届出実績はありません。不具合報告および回収については、いずれも累計0件であり、確認されていません。",{"pma":143,"k510":144,"as_of":146,"events":147,"recalls":148,"top_problems":150},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":37,"latest":145,"applicants":39},"2018-08-27","2026-08",{"death":37,"other":37,"total":37,"injury":37,"last5y":37,"malfunction":37,"latest_month":38},{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":149},[],[],"b5888af33ee87d095d95ececb557bdee73827306008f526948f402a750080822","2026-08-24T05:16:12.270965+00:00",{"items":154,"total":37},[],{"items":156,"total":39},[157],{"k_number":18,"device_name":158,"applicant":159,"decision_date":145,"clearance_type":160,"decision_code":161,"statement_or_summary":162},"DENV Detect NS1 ELISA","InBios International, Inc.","Traditional","SESE","Statement",{"items":164,"total":37},[]]