[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NQL":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":119,"syncDates":120},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":35,"event_count":32},6033,"NQL","System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry","2","862.1055","CH","Clinical Chemistry","1","Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":27,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":27,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":29},{"k_number":17,"fei_number":23,"registration_number":25},[18,19,20,21,22],"DEN040002","K193103","K083130","K173568","K093916",[24],"3002808498",[26],"8043909","","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",3,"2018-05-16",5,0,[],[38,47,56,64,72,80,88,96,104,111],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},3201,"アミロイドβ質量分析用セット","Ⅱ","71088002",0.25641,0.204986,0.622853,0.0320184,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},4433,"質量分析装置","Ⅰ","57848001",0.233766,0.208333,0.627604,0.032002,{"medical_device_id":57,"generic_name":58,"class_classification":41,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},1808,"健康検診システム","70178000",0.147727,0.180328,0.600994,0.0266714,{"medical_device_id":65,"generic_name":66,"class_classification":50,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},3524,"カテコールアミン分析装置","35989000",0.109756,0.162712,0.651437,0.0163934,{"medical_device_id":73,"generic_name":74,"class_classification":50,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},3517,"ラクテート分析装置","35885000",0.0243902,0.245179,0.64109,0.016129,{"medical_device_id":81,"generic_name":82,"class_classification":41,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},1529,"テレメトリー式心拍陣痛計","38479000",0.190476,0.201117,0.483022,0.015873,{"medical_device_id":89,"generic_name":90,"class_classification":41,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},1279,"核医学診断用リング型SPECT装置","40643000",0.170455,0.19774,0.552551,0.015625,{"medical_device_id":97,"generic_name":98,"class_classification":41,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},1289,"X線CT組合せ型SPECT装置","70010020",0.158537,0.209581,0.559589,0.0153846,{"medical_device_id":105,"generic_name":106,"class_classification":50,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":103},3518,"高速液体クロマトグラフィ分析装置","36420000",0.036036,0.21393,0.618552,{"medical_device_id":112,"generic_name":113,"class_classification":41,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118},1624,"定量的感覚検査用温度分析装置","37350000",0.15,0.247216,0.561279,0.0151515,[],{"510k":121,"classification":122,"enforcement":123,"event":124,"pma":125,"warning_letter":126},"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"]