[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KTS":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":104,"syncDates":224,"translation":231,"marketSummary":237,"recalls":250,"k510s":252,"pmas":269},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},2716,"KTS","Second Antibody (Species Specific Anti-Animal Gamma Globulin)","2","866.5510","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":17},[18,19,20,21],"K792637","K781070","K792636","K813508","N","Y","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:48.493322+00:00",0,null,4,[],[32,40,48,55,63,71,78,84,91,97],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":27,"vector_similarity":38,"score":39},1156,"マウス抗体使用冠動脈ステント","Ⅳ","47826004",0.136986,0.569963,0.0305504,{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":27,"vector_similarity":46,"score":47},3523,"グリコヘモグロビン分析装置","Ⅰ","35968000",0.107692,0.569085,0.0289916,{"medical_device_id":49,"generic_name":50,"class_classification":43,"jmdn_code":51,"name_similarity":52,"definition_similarity":27,"vector_similarity":53,"score":54},3580,"微生物感受性分析装置","34574000",0.0985916,0.534018,0.0250078,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":27,"vector_similarity":61,"score":62},1139,"生殖細胞系列遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","Ⅲ","71058003",0.0826446,0.542003,0.0231593,{"medical_device_id":64,"generic_name":65,"class_classification":66,"jmdn_code":67,"name_similarity":68,"definition_similarity":27,"vector_similarity":69,"score":70},1277,"核医学診断用移動型ガンマカメラ","Ⅱ","40641000",0.0843373,0.533844,0.0229915,{"medical_device_id":72,"generic_name":73,"class_classification":66,"jmdn_code":74,"name_similarity":75,"definition_similarity":27,"vector_similarity":76,"score":77},2159,"血液比重検査キット","70363000",0.15873,0.497432,0.0163934,{"medical_device_id":79,"generic_name":80,"class_classification":43,"jmdn_code":81,"name_similarity":82,"definition_similarity":27,"vector_similarity":83,"score":77},3514,"粒子計測免疫測定装置","70181000",0.0361446,0.598751,{"medical_device_id":85,"generic_name":86,"class_classification":66,"jmdn_code":87,"name_similarity":88,"definition_similarity":27,"vector_similarity":89,"score":90},2505,"エアパッド特定加温装置システム","37328020",0.147059,0.38783,0.016129,{"medical_device_id":92,"generic_name":93,"class_classification":43,"jmdn_code":94,"name_similarity":95,"definition_similarity":27,"vector_similarity":96,"score":90},3504,"蛋白質分析装置","30857000",0.0491803,0.58592,{"medical_device_id":98,"generic_name":99,"class_classification":66,"jmdn_code":100,"name_similarity":101,"definition_similarity":27,"vector_similarity":102,"score":103},2501,"エアパッド特定加温装置コントロールユニット","36954020",0.141026,0.396576,0.015873,[105,109,113,117,121,125,129,133,137,140,144,148,151,155,158,161,165,168,171,175,178,181,185,188,191,194,197,200,203,206,209,212,215,218,221],{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"DGC","Ige, Antigen, Antiserum, Control",114,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"DEW","Igg, Antigen, Antiserum, Control",76,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"CFN","Method, Nephelometric, Immunoglobulins (G, A, M)",61,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"CZP","Iga, Antigen, Antiserum, Control",54,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"CFF","Immunoelectrophoretic, Immunoglobulins, (G, A, M)",29,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"DGO","Ige, Peroxidase, Antigen, Antiserum, Control",15,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"CFQ","Radioimmunoassay, Immunoglobulins (G, A, M)",12,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"DFZ","Igg (Gamma Chain Specific), Antigen, Antiserum, Control",9,{"product_code":138,"device_name":139,"device_class":8,"k510_count":136},"JHR","Radioimmunoassay, Immunoglobulins (D, E)",{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"CZJ","Igd, Antigen, Antiserum, Control",8,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"CZN","Iga, Fitc, Antigen, Antiserum, Control",7,{"product_code":149,"device_name":150,"device_class":8,"k510_count":147},"DAH","Gamma Globulin, Antigen, Antiserum, Control",{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"DAA","Igg, Peroxidase, Antigen, Antiserum, Control",5,{"product_code":156,"device_name":157,"device_class":8,"k510_count":29},"CGM","Method, Immunodiffusion, Immunoglobulins (G, A, M)",{"product_code":159,"device_name":160,"device_class":8,"k510_count":29},"DGP","Ige, Fitc, Antigen, Antiserum, Control",{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"DGD","Igg, Ferritin, Antigen, Antiserum, Control",3,{"product_code":166,"device_name":167,"device_class":8,"k510_count":164},"OPX","Immunoglobulin A Kappa Heavy & Light Chain Combined",{"product_code":169,"device_name":170,"device_class":8,"k510_count":164},"PCN","Immunoglobulin G Kappa Heavy And Light Chain Combined",{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"DGE","Igd, Rhodamine, Antigen, Antiserum, Control",2,{"product_code":176,"device_name":177,"device_class":8,"k510_count":174},"DGK","Igg, Fitc, Antigen, Antiserum, Control",{"product_code":179,"device_name":180,"device_class":8,"k510_count":174},"PDE","Immunoglobulin M Kappa Heavy And Light Chain Combined",{"product_code":182,"device_name":183,"device_class":8,"k510_count":184},"CZK","Iga, Rhodamine, Antigen, Antiserum, Control",1,{"product_code":186,"device_name":187,"device_class":8,"k510_count":184},"CZM","Iga, Ferritin, Antigen, Antiserum, Control",{"product_code":189,"device_name":190,"device_class":8,"k510_count":184},"DAF","Gamma Globulin, Fitc, Antigen, Antiserum, Control",{"product_code":192,"device_name":193,"device_class":8,"k510_count":184},"DGH","Igd, Peroxidase, Antigen, Antiserum, Control",{"product_code":195,"device_name":196,"device_class":8,"k510_count":184},"SGG","Mass Spectrometric, Immunoglobulins (G, A, M, D, E)",{"product_code":198,"device_name":199,"device_class":8,"k510_count":27},"CZL","Iga, Peroxidase, Antigen, Antiserum, Control",{"product_code":201,"device_name":202,"device_class":8,"k510_count":27},"DFM","Ige, Ferritin, Antigen, Antiserum, Control",{"product_code":204,"device_name":205,"device_class":8,"k510_count":27},"DFO","Igg, Rhodamine, Antigen, Antiserum, Control",{"product_code":207,"device_name":208,"device_class":8,"k510_count":27},"DGG","Igd, Fitc, Antigen, Antiserum, Control",{"product_code":210,"device_name":211,"device_class":8,"k510_count":27},"DGL","Ige, Rhodamine, Antigen, Antiserum, Control",{"product_code":213,"device_name":214,"device_class":8,"k510_count":27},"MLH","Strip, Hama Igg, Elisa, In Vitro Test System",{"product_code":216,"device_name":217,"device_class":8,"k510_count":27},"OPY","Igal Heavy & Light Chain Combined",{"product_code":219,"device_name":220,"device_class":8,"k510_count":27},"PCO","Immunoglobulin G Lambda Heavy And Light Chain Combined",{"product_code":222,"device_name":223,"device_class":8,"k510_count":27},"PDF","Immunoglobulin M Lambda Heavy And Light Chain Combined",{"510k":225,"classification":226,"enforcement":227,"event":228,"pma":229,"warning_letter":230},"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":232,"definition_ja":28,"commentary_ja":233,"model_name":234,"source_hash":235,"reviewed_by":28,"reviewed_at":28,"created_at":236,"updated_at":236},"種特異的抗動物ガンマグロブリン抗体（第二抗体）","この製品は、免疫測定法において検体中の特定の抗体（第一抗体）を検出するために用いられる、動物種特異的な抗ガンマグロブリン抗体試薬（第二抗体）です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て市販が認められる区分に位置付けられています。","claude-sonnet-5","cfd0ee42a5a503b79c0828ad5603e3d746db3401e3e5ff68d3774583ab0ac946","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":238,"stats":239,"stats_hash":248,"model_name":234,"created_at":249,"updated_at":249},"510(k)の累計届出件数は4件で、3社が申請しています。直近5年間の届出はなく、最新の判定は1981年12月となっています。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、確認されていません。",{"pma":240,"k510":241,"as_of":243,"events":244,"recalls":245,"top_problems":247},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":27,"latest":242,"applicants":164},"1981-12-29","2026-08",{"death":27,"other":27,"total":27,"injury":27,"last5y":27,"malfunction":27,"latest_month":28},{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":246},[],[],"8787a729f09f4c18fb768171b9012a91b37477fd196698992ec53c32cee8774a","2026-08-24T04:46:30.426153+00:00",{"items":251,"total":27},[],{"items":253,"total":29},[254,259,263,265],{"k_number":21,"device_name":255,"applicant":256,"decision_date":242,"clearance_type":257,"decision_code":258,"statement_or_summary":28},"SAC-CEL","Burroughs Wellcome Co.","Traditional","SESE",{"k_number":18,"device_name":260,"applicant":261,"decision_date":262,"clearance_type":257,"decision_code":258,"statement_or_summary":28},"CENTRIA-SET TYPE D(ANTI-SHEEP\u002FGOAT)","Union Carbide Corp.","1980-01-11",{"k_number":20,"device_name":264,"applicant":261,"decision_date":262,"clearance_type":257,"decision_code":258,"statement_or_summary":28},"CENTRIA RADIOIMMUNOASSAY SEPARATION",{"k_number":19,"device_name":266,"applicant":267,"decision_date":268,"clearance_type":257,"decision_code":258,"statement_or_summary":28},"SECOND ANTIBODY","Pcl-Ria, Inc.","1978-08-10",{"items":270,"total":27},[]]