[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QQV":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":122,"syncDates":130,"translation":34,"marketSummary":34,"recalls":137,"k510s":139,"pmas":157},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},5744,"QQV","Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry","2","866.3378","MI","Microbiology","1","An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption\u002Fionization-time of flight mass spectrometry (MALDI-TOF MS).",false,{"openfda":16,"definition":13,"device_name":7,"review_code":28,"device_class":8,"implant_flag":29,"product_code":6,"review_panel":10,"gmp_exempt_flag":29,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":28,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":17,"fei_number":22,"registration_number":27},[18,19,20,21],"K191964","K222563","K193138","K223245",[23,24,25,26],"3002444944","1119779","3010141591","3009288740",[23,24,25,26],"","N","Ineligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",0,null,4,1,[],[39,48,56,64,73,82,90,98,107,115],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},3579,"微生物分類同定分析装置","Ⅰ","34573000",0.186441,0.247093,0.696055,0.031498,{"medical_device_id":49,"generic_name":50,"class_classification":42,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},3577,"血液培養自動分析装置","35617000",0.157025,0.260465,0.718537,0.0310993,{"medical_device_id":57,"generic_name":58,"class_classification":42,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},4433,"質量分析装置","57848001",0.152542,0.236181,0.701491,0.0297619,{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},3201,"アミロイドβ質量分析用セット","Ⅱ","71088002",0.158333,0.205128,0.677852,0.0294372,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},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）","Ⅲ","71059003",0.2125,0.233146,0.636902,0.0290517,{"medical_device_id":83,"generic_name":84,"class_classification":42,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},3719,"組織培養用試料調整容器","70369000",0.208,0.188312,0.636604,0.028629,{"medical_device_id":91,"generic_name":92,"class_classification":42,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},3572,"自動尿スクリーニングシステム","30648000",0.138211,0.201581,0.70376,0.0274927,{"medical_device_id":99,"generic_name":100,"class_classification":101,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},1182,"心臓用補綴材留置用デリバリーシステム","Ⅳ","45419004",0.193103,0.177419,0.550104,0.015625,{"medical_device_id":108,"generic_name":109,"class_classification":76,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},1165,"体細胞遺伝子変異解析セット（抗悪性腫瘍薬適応判定用）","71059023",0.171779,0.20303,0.589553,0.0153846,{"medical_device_id":116,"generic_name":117,"class_classification":42,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":114},3536,"微生物由来成分分析装置","70183000",0.0703125,0.120438,0.690076,[123,126],{"product_code":124,"device_name":125,"device_class":8,"k510_count":35},"QBN","Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates",{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"QNJ","Mass Spectrometry, Microorganism Identification, Blood Culture",2,{"510k":131,"classification":132,"enforcement":133,"event":134,"pma":135,"warning_letter":136},"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","2026-08-20T03:28:02.95+00:00",{"items":138,"total":33},[],{"items":140,"total":35},[141,148,152,155],{"k_number":19,"device_name":142,"applicant":143,"decision_date":144,"clearance_type":145,"decision_code":146,"statement_or_summary":147},"BD Kiestra IdentifA","Becton, Dickinson and Company","2023-08-31","Traditional","SESE","Summary",{"k_number":21,"device_name":149,"applicant":150,"decision_date":151,"clearance_type":145,"decision_code":146,"statement_or_summary":147},"Colibrí","Copan Wasp Srl","2023-03-20",{"k_number":20,"device_name":153,"applicant":150,"decision_date":154,"clearance_type":145,"decision_code":146,"statement_or_summary":147},"Colibri System","2021-12-27",{"k_number":18,"device_name":142,"applicant":143,"decision_date":156,"clearance_type":145,"decision_code":146,"statement_or_summary":147},"2021-11-03",{"items":158,"total":33},[]]