[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OZB":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":115,"syncDates":116,"translation":123,"marketSummary":130,"recalls":143,"k510s":145,"pmas":152},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":32,"event_count":32},2629,"OZB","Dengue Nucleic Acid Amplification Assay (Naat)","2","866.3946","MI","Microbiology","1","A qualitative in vitro diagnostic assay for the detection of dengue  virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).",false,{"openfda":16,"definition":13,"device_name":7,"review_code":27,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":27,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":29},{"k_number":17,"fei_number":19,"registration_number":24},[18],"DEN120012",[20,21,22,23],"1050190","3005670738","3003952975","2243471",[23,25,26,20],"2032682","3005360469","","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:47.656965+00:00",0,null,1,[],[37,46,53,61,68,77,84,92,99,108],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},3514,"粒子計測免疫測定装置","Ⅰ","70181000",0.08,0.126016,0.627314,0.0163934,{"medical_device_id":47,"generic_name":48,"class_classification":40,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":45},3579,"微生物分類同定分析装置","34573000",0.15625,0.173252,0.58401,{"medical_device_id":54,"generic_name":55,"class_classification":40,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},3510,"免疫蛍光分析装置","35707010",0.0147059,0.196078,0.626713,0.016129,{"medical_device_id":62,"generic_name":63,"class_classification":40,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":60},3736,"歯科用薬剤注入器","70387000",0.15,0.182836,0.409757,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},1304,"超音波増幅器","Ⅱ","36370000",0.145455,0.198171,0.554701,0.015873,{"medical_device_id":78,"generic_name":79,"class_classification":40,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":76},3511,"移動式免疫蛍光分析装置","35707020",0.0133333,0.195364,0.626349,{"medical_device_id":85,"generic_name":86,"class_classification":40,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},3503,"デンシトメトリー分析装置","15129000",0.0666667,0.184211,0.618467,0.015625,{"medical_device_id":93,"generic_name":94,"class_classification":40,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":91},3964,"非能動型簡易型牽引装置","35519001",0.153846,0.131579,0.435099,{"medical_device_id":100,"generic_name":101,"class_classification":102,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},688,"植込み型病変識別マーカ","Ⅲ","40808000",0.142857,0.174026,0.527329,0.0153846,{"medical_device_id":109,"generic_name":110,"class_classification":40,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":107},3502,"蛋白分画電気泳動分析装置","31365000",0.0609756,0.188119,0.618458,[],{"510k":117,"classification":118,"enforcement":119,"event":120,"pma":121,"warning_letter":122},"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":124,"definition_ja":125,"commentary_ja":126,"model_name":127,"source_hash":128,"reviewed_by":33,"reviewed_at":33,"created_at":129,"updated_at":129},"デングウイルス核酸増幅検出キット","本品は、デング熱（軽症または重症）に合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血清または血漿検体中のデングウイルス血清型1、2、3または4を検出するための定性的なインビトロ診断アッセイである。","米国ではクラスIIに分類され、市販前届出（510(k)）による審査を経て市場に出すことが認められています。クラスIIは中程度のリスクを有する医療機器区分であり、実質的同等性を既存品と比較検証することで安全性・有効性を確認する仕組みとなっています。","claude-sonnet-5","c84196cfdd709f0723fe80b1214c6e7e6cde8e7ae91b9b4184f2357731d6bfa6","2026-08-24T02:26:34.466715+00:00",{"product_code":6,"summary_ja":131,"stats":132,"stats_hash":141,"model_name":127,"created_at":142,"updated_at":142},"本製品コードにおける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年間の届出はありません。不具合報告（MDR）および回収の実績は確認されていません。",{"pma":133,"k510":134,"as_of":136,"events":137,"recalls":138,"top_problems":140},{"latest":33,"originals":32,"supplements":32},{"total":34,"last5y":32,"latest":135,"applicants":34},"2012-05-24","2026-08",{"death":32,"other":32,"total":32,"injury":32,"last5y":32,"malfunction":32,"latest_month":33},{"total":32,"last5y":32,"latest":33,"class_i":32,"class_ii":32,"class_iii":32,"top_root_causes":139},[],[],"4689dbd1fb22fe0002db359f27f29567c3748696a6f0e8d6852ac599e4ccfb11","2026-08-24T05:07:49.137996+00:00",{"items":144,"total":32},[],{"items":146,"total":34},[147],{"k_number":18,"device_name":148,"applicant":149,"decision_date":135,"clearance_type":150,"decision_code":151,"statement_or_summary":33},"CDC DENV-1-4 REAL TIME RT-PCT ASSAY","Centers for Disease Control and Prevention","Post-NSE","DENG",{"items":153,"total":32},[]]