[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GQN":3},{"classification":4,"mappedDevices":66,"similarCandidates":67,"relatedClassifications":138,"syncDates":170},{"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":61,"updated_at":62,"recall_count":63,"latest_recall_date":64,"k510_count":65,"pma_count":63,"event_count":63},1426,"GQN","Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2","2","866.3305","MI","Microbiology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":59,"product_code":6,"review_panel":10,"gmp_exempt_flag":59,"third_party_flag":59,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":59,"medical_specialty_description":11,"summary_malfunction_reporting":60},{"k_number":17,"fei_number":52,"registration_number":56},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"K971101","K063798","K832875","K870733","K875311","K853307","K801721","K991880","K854488","K884761","K070265","K971662","K842830","K791614","K854974","K964874","K870602","K873529","K883684","K850609","K843751","K872632","K941924","K960578","K811021","K874863","K911345","K881180","K880604","K843658","K832541","K880996","K880436","K841191",[53,54,55],"3006224287","1000122536","3003750284",[57,58,55],"1528450","8010096","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",0,null,34,[],[68,76,83,90,97,104,111,117,125,131],{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":63,"vector_similarity":74,"score":75},2174,"輸液セット用コントローラ","Ⅱ","36244000",0.173333,0.537983,0.0293236,{"medical_device_id":77,"generic_name":78,"class_classification":71,"jmdn_code":79,"name_similarity":80,"definition_similarity":63,"vector_similarity":81,"score":82},2488,"ウォーターパッド特定加温装置コントロールユニット","36956020",0.151899,0.534968,0.0276506,{"medical_device_id":84,"generic_name":85,"class_classification":71,"jmdn_code":86,"name_similarity":87,"definition_similarity":63,"vector_similarity":88,"score":89},2487,"ウォーターパッド加温装置コントロールユニット","36956010",0.171429,0.532471,0.0268789,{"medical_device_id":91,"generic_name":92,"class_classification":71,"jmdn_code":93,"name_similarity":94,"definition_similarity":63,"vector_similarity":95,"score":96},2500,"エアパッド加温装置コントロールユニット","36954010",0.19403,0.495639,0.0163934,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":63,"vector_similarity":103,"score":96},3514,"粒子計測免疫測定装置","Ⅰ","70181000",0.097561,0.573614,{"medical_device_id":105,"generic_name":106,"class_classification":71,"jmdn_code":107,"name_similarity":108,"definition_similarity":63,"vector_similarity":109,"score":110},2480,"天蓋加温装置コントロールユニット","36953000",0.181818,0.519342,0.016129,{"medical_device_id":112,"generic_name":113,"class_classification":100,"jmdn_code":114,"name_similarity":115,"definition_similarity":63,"vector_similarity":116,"score":110},3450,"再使用可能な内視鏡用細胞診ブラシ","38833000",0.0238095,0.57274,{"medical_device_id":118,"generic_name":119,"class_classification":120,"jmdn_code":121,"name_similarity":122,"definition_similarity":63,"vector_similarity":123,"score":124},666,"コラーゲン使用体内用失禁補綴材","Ⅲ","34214200",0.174419,0.464997,0.015873,{"medical_device_id":126,"generic_name":127,"class_classification":100,"jmdn_code":128,"name_similarity":129,"definition_similarity":63,"vector_similarity":130,"score":124},3451,"単回使用内視鏡用細胞診ブラシ","38834000",0.0352941,0.566684,{"medical_device_id":132,"generic_name":133,"class_classification":120,"jmdn_code":134,"name_similarity":135,"definition_similarity":63,"vector_similarity":136,"score":137},474,"ヘパリン使用成分採血セット","70405000",0.0958904,0.565172,0.015625,[139,143,147,151,155,159,163,167],{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"LGC","Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific",38,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"GQL","Antisera, Fluorescent, Herpesvirus Hominis 1,2",37,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"MXJ","Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1",20,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"GQO","Antisera, Cf, Herpesvirus Hominis 1,2",16,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"OQO","Herpes Simplex Virus Nucleic Acid Amplification Assay",12,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"MYF","Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2",10,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"GQM","Antisera, Neutralization, Herpesvirus Hominis",3,{"product_code":168,"device_name":169,"device_class":8,"k510_count":63},"LKC","Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus",{"510k":171,"classification":172,"enforcement":173,"event":174,"pma":175,"warning_letter":176},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]