[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OZN":3},{"classification":4,"mappedDevices":62,"similarCandidates":63,"relatedClassifications":145,"syncDates":146},{"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":55,"updated_at":56,"recall_count":57,"latest_recall_date":58,"k510_count":59,"pma_count":60,"event_count":61},3537,"OZN","C. Difficile Toxin Gene Amplification Assay","2","866.3130","MI","Microbiology","1","Amplification assay for the detection of c. Difficile toxin genes from stool specimens of  symptomatic patients.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":52,"device_class":8,"implant_flag":53,"product_code":6,"review_panel":10,"gmp_exempt_flag":53,"third_party_flag":53,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":52,"life_sustain_support_flag":53,"medical_specialty_description":11,"summary_malfunction_reporting":54},{"k_number":17,"fei_number":35,"registration_number":49},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34],"K243730","K172569","K132726","K130470","K133936","K123998","K171441","K163085","K171770","K123197","K210385","K142422","K132235","K123355","K232092","K170491","K212427",[36,37,38,39,40,41,42,43,44,45,46,47,48],"3004141078","3003795116","3006028115","3004013603","1524213","2243471","2023365","3012494290","3007420875","3012918440","1119779","1000122536","3002806559",[50,51,36,37,38,39,40,41,42,43,44,45,46],"1528450","9610126","","N","Ineligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",8,"2026-01-14",17,0,31,[],[64,73,82,90,98,106,115,122,130,137],{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},3579,"微生物分類同定分析装置","Ⅰ","34573000",0.140625,0.160448,0.62292,0.0305504,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},1162,"生殖細胞系列遺伝子変異解析プログラム（罹患リスク判定用）","Ⅲ","71058013",0.141414,0.206751,0.600622,0.0301587,{"medical_device_id":83,"generic_name":84,"class_classification":76,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},1140,"体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用）","71059003",0.133929,0.175824,0.585563,0.0251414,{"medical_device_id":91,"generic_name":92,"class_classification":76,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},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）","71058003",0.126126,0.192,0.589968,0.0247253,{"medical_device_id":99,"generic_name":100,"class_classification":76,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},1153,"体細胞遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","70159013",0.132743,0.174797,0.583857,0.0237693,{"medical_device_id":107,"generic_name":108,"class_classification":109,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},2146,"トロカール装着用カフ","Ⅱ","70351000",0.181818,0.108911,0.431895,0.0163934,{"medical_device_id":116,"generic_name":117,"class_classification":67,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":114},3591,"遺伝子解析装置","70192000",0.122449,0.173469,0.656281,{"medical_device_id":123,"generic_name":124,"class_classification":109,"jmdn_code":125,"name_similarity":126,"definition_similarity":127,"vector_similarity":128,"score":129},2139,"人工授精用カテーテル","70345010",0.15625,0.143646,0.485785,0.016129,{"medical_device_id":131,"generic_name":132,"class_classification":67,"jmdn_code":133,"name_similarity":134,"definition_similarity":135,"vector_similarity":136,"score":129},3525,"クレアチニン分析装置","35991000",0.0701754,0.167539,0.631736,{"medical_device_id":138,"generic_name":139,"class_classification":67,"jmdn_code":140,"name_similarity":141,"definition_similarity":142,"vector_similarity":143,"score":144},4202,"アデノトーム","10025000",0.02,0.0944882,0.628779,0.015873,[],{"510k":147,"classification":148,"enforcement":149,"event":150,"pma":151,"warning_letter":152},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]