[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QZJ":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":116,"syncDates":177,"translation":184,"marketSummary":191,"recalls":204,"k510s":206,"pmas":208},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":29,"pma_count":31,"event_count":29},2338,"QZJ","Immunohistochemistry Assay, Antibody, Claudin 18","3","864.1860","HE","Hematology","PA","2","The Claudin 18 antibody is a qualitative immunohistochemical antibody intended to identify CLDN18 protein expression in human clinical tissue specimens. The CLDN18 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":24,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":12,"gmp_exempt_flag":25,"third_party_flag":25,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":24,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"fei_number":18,"pma_number":20,"registration_number":22},[19],"1000125183",[21],"P230018",[23],"2028492","","N","Ineligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:48.095002+00:00",0,null,2,[],[34,43,51,59,67,75,84,92,100,108],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},3505,"酵素免疫測定装置","Ⅰ","35706010",0.196721,0.152824,0.643093,0.0315136,{"medical_device_id":44,"generic_name":45,"class_classification":37,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},3512,"免疫発光測定装置","36223010",0.238806,0.211356,0.621077,0.0308862,{"medical_device_id":52,"generic_name":53,"class_classification":37,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},3555,"ラジオイムノアッセイ用装置","35506000",0.163934,0.224868,0.647612,0.030478,{"medical_device_id":60,"generic_name":61,"class_classification":37,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},3513,"移動式免疫発光測定装置","36223020",0.216216,0.219355,0.619459,0.0304147,{"medical_device_id":68,"generic_name":69,"class_classification":37,"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",0.176471,0.159864,0.638011,0.0303658,{"medical_device_id":76,"generic_name":77,"class_classification":78,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},1156,"マウス抗体使用冠動脈ステント","Ⅳ","47826004",0.157143,0.187879,0.634571,0.0290832,{"medical_device_id":85,"generic_name":86,"class_classification":37,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},3510,"免疫蛍光分析装置","35707010",0.125,0.156342,0.635054,0.028125,{"medical_device_id":93,"generic_name":94,"class_classification":37,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.179104,0.18018,0.608508,0.0278638,{"medical_device_id":101,"generic_name":102,"class_classification":37,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},3514,"粒子計測免疫測定装置","70181000",0.2,0.143396,0.598605,0.0273897,{"medical_device_id":109,"generic_name":110,"class_classification":37,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},3511,"移動式免疫蛍光分析装置","35707020",0.112676,0.162162,0.623678,0.0271205,[117,121,125,128,132,136,139,143,147,150,153,156,159,162,165,168,171,174],{"product_code":118,"device_name":119,"device_class":13,"k510_count":120},"NQN","Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity",15,{"product_code":122,"device_name":123,"device_class":13,"k510_count":124},"MXZ","Immunohistochemistry Assay, Antibody, Progesterone Receptor",13,{"product_code":126,"device_name":127,"device_class":13,"k510_count":124},"NOT","Microscope, Automated, Image Analysis, Operator Intervention",{"product_code":129,"device_name":130,"device_class":13,"k510_count":131},"MYA","Immunohistochemistry Antibody Assay, Estrogen Receptor",12,{"product_code":133,"device_name":134,"device_class":13,"k510_count":135},"OEO","Automated Digital Image Manual Interpretation Microscope",6,{"product_code":137,"device_name":138,"device_class":13,"k510_count":31},"NJW","Control Material, Her-2\u002FNeu, Immunohistochemistry",{"product_code":140,"device_name":141,"device_class":13,"k510_count":142},"NBK","System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer",1,{"product_code":144,"device_name":145,"device_class":146,"k510_count":142},"NTR","Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells","1",{"product_code":148,"device_name":149,"device_class":8,"k510_count":29},"LPI","Kit, Assay, Progesterone Receptor",{"product_code":151,"device_name":152,"device_class":8,"k510_count":29},"LPJ","Kit, Assay, Estrogen Receptor",{"product_code":154,"device_name":155,"device_class":146,"k510_count":29},"NJT","Immunohistochemistry Reagents And Kits",{"product_code":157,"device_name":158,"device_class":8,"k510_count":29},"NKF","Immunohistochemistry Antibody Assay, C-Kit",{"product_code":160,"device_name":161,"device_class":8,"k510_count":29},"NQF","Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor",{"product_code":163,"device_name":164,"device_class":8,"k510_count":29},"QKF","Immunocytochemistry Assay, P16\u002FKi-67",{"product_code":166,"device_name":167,"device_class":8,"k510_count":29},"QNH","Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay",{"product_code":169,"device_name":170,"device_class":8,"k510_count":29},"QUL","Immunohistochemistry Assay, Antibody, Folr1",{"product_code":172,"device_name":173,"device_class":8,"k510_count":29},"SBL","Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4",{"product_code":175,"device_name":176,"device_class":8,"k510_count":29},"SER","Immunohistochemistry Assay, Antibody, Met",{"510k":178,"classification":179,"enforcement":180,"event":181,"pma":182,"warning_letter":183},"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":185,"definition_ja":186,"commentary_ja":187,"model_name":188,"source_hash":189,"reviewed_by":30,"reviewed_at":30,"created_at":190,"updated_at":190},"免疫組織化学検査用クローディン18抗体","クローディン18抗体は、ヒト臨床組織検体におけるCLDN18タンパク質の発現を同定することを目的とした定性的免疫組織化学用抗体である。CLDN18抗体は、特定のFDA承認治療薬による治療に適格な患者を特定するための補助として使用されることが意図されている。","本品は米国においてクラスIIIに分類されており、市販前承認（PMA）による審査を経て市場に出されます。クラスIIIはFDAの分類制度の中で最も規制が厳格な区分であり、特定の治療薬の適応判定に用いられるコンパニオン診断的な性格を持つ製品などがこの区分に該当します。","claude-sonnet-5","733b4dc367b74959ba9545c00d3068cd26488f7a34d1eb167d8e5c30fe70c14e","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":192,"stats":193,"stats_hash":202,"model_name":188,"created_at":203,"updated_at":203},"本製品はPMA（市販前承認）区分の機器で、本承認が1件、一部変更承認が1件申請されており、最新の判定は2025年6月です。不具合報告（MDR）の累計は確認されていません。また、回収についても累計・直近5年ともに確認されていません。",{"pma":194,"k510":196,"as_of":197,"events":198,"recalls":199,"top_problems":201},{"latest":195,"originals":142,"supplements":142},"2025-06-20",{"total":29,"last5y":29,"latest":30,"applicants":29},"2026-08",{"death":29,"other":29,"total":29,"injury":29,"last5y":29,"malfunction":29,"latest_month":30},{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":200},[],[],"c46bf49ec6567553bcaa0221ca3814a25d42ae4962cc698ef51be4143ef5fda4","2026-08-24T05:22:13.607018+00:00",{"items":205,"total":29},[],{"items":207,"total":29},[],{"items":209,"total":31},[210,214],{"pma_number":21,"supplement_number":211,"trade_name":212,"applicant":213,"decision_date":195},"S001","VENTANA CLDN18 (43-14A) RxDx Assay","Ventana Medical Systems, Inc.",{"pma_number":21,"supplement_number":24,"trade_name":212,"applicant":213,"decision_date":215},"2024-10-18"]