[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PMN":3},{"classification":4,"mappedDevices":74,"similarCandidates":75,"relatedClassifications":156,"syncDates":163},{"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":67,"updated_at":68,"recall_count":69,"latest_recall_date":70,"k510_count":71,"pma_count":72,"event_count":73},4365,"PMN","Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays","2","866.3920","MI","Microbiology","1","Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":51,"device_class":8,"implant_flag":64,"product_code":6,"review_panel":10,"gmp_exempt_flag":64,"third_party_flag":65,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":51,"life_sustain_support_flag":64,"medical_specialty_description":11,"summary_malfunction_reporting":66},{"k_number":17,"fei_number":50,"registration_number":62},[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],"K190463","K231223","K190086","K161573","DEN150058","K203680","K181711","K260041","K191172","K191168","K202382","K230868","K190223","K260577","K261475","K241289","K251526","K231221","K200010","K212576","K190222","K182472","K221253","K254167","K201403","K152679","K202196","K163522","K254166","K181683","K233611","K173171",[51,52,53,54,55,56,57,58,59,60,61],"","2150138","3005959679","3010770794","2023365","2024674","1950302","2024800","1000122536","2016706","3010127294",[63,51,52,53,54,55,56,57,58,60,61],"1528450","N","Y","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",4,"2019-06-26",32,0,1,[],[76,85,93,102,109,117,124,133,140,149],{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},4449,"咀嚼能力検査用物質","Ⅰ","71093001",0.163265,0.177419,0.615086,0.0276506,{"medical_device_id":86,"generic_name":87,"class_classification":79,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},3579,"微生物分類同定分析装置","34573000",0.170213,0.139932,0.612,0.0272711,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},1078,"抗菌性カテーテル被覆・保護材","Ⅲ","47937003",0.193548,0.108303,0.545362,0.0163934,{"medical_device_id":103,"generic_name":104,"class_classification":79,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":101},3555,"ラジオイムノアッセイ用装置","35506000",0.050505,0.142433,0.655829,{"medical_device_id":110,"generic_name":111,"class_classification":96,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},1052,"医薬品含有歯科根管切削補助材","70928003",0.184211,0.160584,0.549189,0.016129,{"medical_device_id":118,"generic_name":119,"class_classification":79,"jmdn_code":120,"name_similarity":121,"definition_similarity":122,"vector_similarity":123,"score":116},3572,"自動尿スクリーニングシステム","30648000",0.0377358,0.167598,0.646053,{"medical_device_id":125,"generic_name":126,"class_classification":127,"jmdn_code":128,"name_similarity":129,"definition_similarity":130,"vector_similarity":131,"score":132},2658,"歯科メタルセラミック修復用貴金属材料","Ⅱ","70770000",0.183486,0.147186,0.477218,0.015873,{"medical_device_id":134,"generic_name":135,"class_classification":79,"jmdn_code":136,"name_similarity":137,"definition_similarity":138,"vector_similarity":139,"score":132},3526,"窒素分析装置","36741000",0.0434783,0.184049,0.634473,{"medical_device_id":141,"generic_name":142,"class_classification":143,"jmdn_code":144,"name_similarity":145,"definition_similarity":146,"vector_similarity":147,"score":148},1084,"中心循環系非吸収性局所止血材","Ⅳ","31744024",0.178862,0.158798,0.499582,0.015625,{"medical_device_id":150,"generic_name":151,"class_classification":79,"jmdn_code":152,"name_similarity":153,"definition_similarity":154,"vector_similarity":155,"score":148},3488,"ディスクリート方式臨床化学自動分析装置","35743010",0.0695652,0.105651,0.630886,[157,160],{"product_code":158,"device_name":159,"device_class":8,"k510_count":73},"QCH","Assayed Quality Control Material For Clinical Microbiology Assays",{"product_code":161,"device_name":162,"device_class":8,"k510_count":72},"QTM","Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.",{"510k":164,"classification":165,"enforcement":166,"event":167,"pma":168,"warning_letter":169},"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"]