[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QBX":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":110,"syncDates":115},{"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":27,"pma_count":25,"event_count":28},2615,"QBX","Direct Blood Bacterial Nucleic Acid Detection System","2","866.3960","MI","Microbiology","1","Amplification, detection and identification of microbial pathogens directly from whole blood specimens",false,{"openfda":16,"definition":13,"device_name":7,"review_code":20,"device_class":8,"implant_flag":21,"product_code":6,"review_panel":10,"gmp_exempt_flag":21,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":20,"life_sustain_support_flag":21,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":17},[18,19],"K172708","K233184","","N","Ineligible","2026-08-18T05:52:50.495594+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,55,[],[31,40,49,57,64,73,80,88,95,103],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":37,"vector_similarity":38,"score":39},699,"透析装置用血液漏出検知器","Ⅲ","32128000",0.313433,0.173653,0.626122,0.0277571,{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3579,"微生物分類同定分析装置","Ⅰ","34573000",0.0512821,0.222672,0.724517,0.0163934,{"medical_device_id":50,"generic_name":51,"class_classification":34,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},698,"透析装置用血液量検知器","32127000",0.308824,0.156863,0.61792,0.016129,{"medical_device_id":58,"generic_name":59,"class_classification":43,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":56},3577,"血液培養自動分析装置","35617000",0.0933333,0.175637,0.699982,{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},2122,"採血バッグ付胸腔排液用装置","Ⅱ","70332010",0.261905,0.133333,0.568505,0.015873,{"medical_device_id":74,"generic_name":75,"class_classification":43,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":72},3536,"微生物由来成分分析装置","70183000",0.0394737,0.146497,0.699085,{"medical_device_id":81,"generic_name":82,"class_classification":34,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},704,"透析用血液循環ユニット","36428000",0.256757,0.135484,0.505048,0.015625,{"medical_device_id":89,"generic_name":90,"class_classification":34,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":87},1166,"マラリア診断装置","71081003",0.169231,0.157407,0.690283,{"medical_device_id":96,"generic_name":97,"class_classification":67,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},1278,"核医学診断用検出器回転型SPECT装置","40642000",0.246753,0.11244,0.526366,0.0153846,{"medical_device_id":104,"generic_name":105,"class_classification":43,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":102},3569,"血液型分析装置","35635000",0.0886076,0.145729,0.677583,[111],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"PII","Candida Species Nucleic Acid Detection System",3,{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]