[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DEZ":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":100,"syncDates":149,"translation":156,"marketSummary":162,"recalls":177,"k510s":179,"pmas":181},{"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":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":25,"pma_count":25,"event_count":27},2178,"DEZ","Igm, Rhodamine, Antigen, Antiserum, Control","2","866.5550","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"fei_number":17,"registration_number":19},[18],"3019906",[18],"N","Y","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:49.029844+00:00",0,null,3,[],[30,38,46,54,60,67,73,80,87,93],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":25,"vector_similarity":36,"score":37},3277,"X線自動露出制御器","Ⅰ","34311000",0.169492,0.589128,0.0305789,{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":25,"vector_similarity":44,"score":45},456,"注射筒輸液ポンプコントロールユニット","Ⅲ","37217000",0.145161,0.567783,0.0256536,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":25,"vector_similarity":52,"score":53},2446,"酸素コントローラ","Ⅱ","70577000",0.2,0.531542,0.0163934,{"medical_device_id":55,"generic_name":56,"class_classification":33,"jmdn_code":57,"name_similarity":58,"definition_similarity":25,"vector_similarity":59,"score":53},3514,"粒子計測免疫測定装置","70181000",0.102941,0.640151,{"medical_device_id":61,"generic_name":62,"class_classification":49,"jmdn_code":63,"name_similarity":64,"definition_similarity":25,"vector_similarity":65,"score":66},2556,"トレパンシステムコントロールユニット","43928000",0.181818,0.549107,0.016129,{"medical_device_id":68,"generic_name":69,"class_classification":33,"jmdn_code":70,"name_similarity":71,"definition_similarity":25,"vector_similarity":72,"score":66},3510,"免疫蛍光分析装置","35707010",0.0677966,0.636677,{"medical_device_id":74,"generic_name":75,"class_classification":33,"jmdn_code":76,"name_similarity":77,"definition_similarity":25,"vector_similarity":78,"score":79},3511,"移動式免疫蛍光分析装置","35707020",0.0606061,0.629544,0.015873,{"medical_device_id":81,"generic_name":82,"class_classification":49,"jmdn_code":83,"name_similarity":84,"definition_similarity":25,"vector_similarity":85,"score":86},2500,"エアパッド加温装置コントロールユニット","36954010",0.160714,0.47661,0.015625,{"medical_device_id":88,"generic_name":89,"class_classification":33,"jmdn_code":90,"name_similarity":91,"definition_similarity":25,"vector_similarity":92,"score":86},3509,"移動式免疫比濁分析装置","35926020",0.0588235,0.616743,{"medical_device_id":94,"generic_name":95,"class_classification":49,"jmdn_code":96,"name_similarity":97,"definition_similarity":25,"vector_similarity":98,"score":99},2174,"輸液セット用コントローラ","36244000",0.15873,0.541745,0.0153846,[101,105,109,113,117,120,123,126,130,133,136,140,143,146],{"product_code":102,"device_name":103,"device_class":8,"k510_count":104},"DFH","Kappa, Antigen, Antiserum, Control",63,{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"DEH","Lambda, Antigen, Antiserum, Control",53,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"DFT","Igm, Antigen, Antiserum, Control",33,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"DAO","Igm (Mu Chain Specific), Antigen, Antiserum, Control",8,{"product_code":118,"device_name":119,"device_class":8,"k510_count":27},"DEY","Igm, Peroxidase, Antigen, Antiserum, Control",{"product_code":121,"device_name":122,"device_class":8,"k510_count":27},"DFD","Kappa, Peroxidase, Antigen, Antiserum, Control",{"product_code":124,"device_name":125,"device_class":8,"k510_count":27},"DFL","Igm, Ferritin, Antigen, Antiserum, Control",{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"DEO","Kappa, Fitc, Antigen, Antiserum, Control",2,{"product_code":131,"device_name":132,"device_class":8,"k510_count":129},"DES","Lambda, Fitc, Antigen, Antiserum, Control",{"product_code":134,"device_name":135,"device_class":8,"k510_count":129},"LYE","Cytokeratins",{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"DEP","Lambda, Peroxidase, Antigen, Antiserum, Control",1,{"product_code":141,"device_name":142,"device_class":8,"k510_count":139},"DFG","Lambda, Rhodamine, Antigen, Antiserum, Control",{"product_code":144,"device_name":145,"device_class":8,"k510_count":139},"DFS","Igm, Fitc, Antigen, Antiserum, Control",{"product_code":147,"device_name":148,"device_class":8,"k510_count":25},"DEK","Kappa, Rhodamine, Antigen, Antiserum, Control",{"510k":150,"classification":151,"enforcement":152,"event":153,"pma":154,"warning_letter":155},"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":157,"definition_ja":26,"commentary_ja":158,"model_name":159,"source_hash":160,"reviewed_by":26,"reviewed_at":26,"created_at":161,"updated_at":161},"IgM抗原・抗血清・コントロール（ローダミン標識）","本品は、ローダミンで標識した抗原、抗血清および対照品から構成される、免疫グロブリンM（IgM）を検出・測定するための免疫学的検査システムです。米国ではクラスIIに分類され、市販に先立り市販前届出（510(k)）による審査を経て安全性・有効性が確認される区分に位置付けられています。","claude-sonnet-5","2c50adea0d5541a03705ec3677f6ae366a2cbfc16ab276489e19da66e97b2427","2026-08-24T01:46:26.815929+00:00",{"product_code":6,"summary_ja":163,"stats":164,"stats_hash":175,"model_name":159,"created_at":176,"updated_at":176},"不具合報告（MDR）は累計約3件確認されており、そのすべてが傷害（Injury）報告で、死亡や不具合（Malfunction）の報告は確認されていません。主な問題としては、骨結合不全（Failure to Osseointegrate）や患者・機器間の適合に関する問題（Patient Device Interaction Problem）が挙げられています。510(k)およびPMAの届出実績、ならびに回収の実績はいずれも確認されていません。",{"pma":165,"k510":166,"as_of":167,"events":168,"recalls":170,"top_problems":172},{"latest":26,"originals":25,"supplements":25},{"total":25,"last5y":25,"latest":26,"applicants":25},"2026-08",{"death":25,"other":25,"total":27,"injury":27,"last5y":27,"malfunction":25,"latest_month":169},"2026-05",{"total":25,"last5y":25,"latest":26,"class_i":25,"class_ii":25,"class_iii":25,"top_root_causes":171},[],[173,174],"Failure to Osseointegrate","Patient Device Interaction Problem","fd6b51ed42743aebf0fa6cbcdf58659d6a79177217ed854dfb9040957f4b8b3e","2026-08-24T04:11:59.548648+00:00",{"items":178,"total":25},[],{"items":180,"total":25},[],{"items":182,"total":25},[]]