[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ORA":3},{"classification":4,"mappedDevices":25,"similarCandidates":26,"relatedClassifications":108,"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":20,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":24,"pma_count":24,"event_count":24},4262,"ORA","Breast Milk-Alcohol Test System","2","862.3040","TX","Clinical Toxicology","1","Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":17,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":10,"gmp_exempt_flag":18,"third_party_flag":18,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":17,"life_sustain_support_flag":18,"medical_specialty_description":11,"summary_malfunction_reporting":19},{},"","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",1,"2023-11-01",0,[],[27,36,44,52,61,69,78,85,93,100],{"medical_device_id":28,"generic_name":29,"class_classification":30,"jmdn_code":31,"name_similarity":32,"definition_similarity":33,"vector_similarity":34,"score":35},1624,"定量的感覚検査用温度分析装置","Ⅱ","37350000",0.19697,0.174174,0.622647,0.0307765,{"medical_device_id":37,"generic_name":38,"class_classification":30,"jmdn_code":39,"name_similarity":40,"definition_similarity":41,"vector_similarity":42,"score":43},1808,"健康検診システム","70178000",0.226415,0.119149,0.594443,0.0295513,{"medical_device_id":45,"generic_name":46,"class_classification":30,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},1352,"マイクロ波サーモグラフィ装置","40802000",0.196078,0.11276,0.587648,0.0271205,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},3322,"アルコール毛細管体温計","Ⅰ","34343000",0.173077,0.174603,0.592902,0.0261717,{"medical_device_id":62,"generic_name":63,"class_classification":55,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},3572,"自動尿スクリーニングシステム","30648000",0.145455,0.0898876,0.653312,0.0163934,{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},788,"麻酔システム","Ⅲ","37710000",0.219512,0.13289,0.492794,0.016129,{"medical_device_id":79,"generic_name":80,"class_classification":30,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":77},1238,"据置型デジタル式乳房用X線診断装置","37672000",0.106667,0.125301,0.641066,{"medical_device_id":86,"generic_name":87,"class_classification":30,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1240,"ポータブルデジタル式乳房用X線診断装置","37674000",0.108108,0.120205,0.62966,0.015873,{"medical_device_id":94,"generic_name":95,"class_classification":30,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":92},2475,"マイクロ波治療器","11245000",0.217391,0.144578,0.54962,{"medical_device_id":101,"generic_name":102,"class_classification":30,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},1239,"移動型デジタル式乳房用X線診断装置","37673000",0.112676,0.129442,0.628797,0.015625,[109,113,117,121,125,128,131,134,137,140,143],{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"DIC","Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method",33,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"DML","Nad-Nadh, Specific Reagent For Alcohol Enzyme Method",13,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"DMT","Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet",8,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"DOJ","Potassium Dichromate, Alcohol",2,{"product_code":126,"device_name":127,"device_class":8,"k510_count":22},"DMI","Potassium Dichromate Specific Reagent For Alcohol",{"product_code":129,"device_name":130,"device_class":8,"k510_count":24},"DIZ","Delayed Analysis, Alcohol",{"product_code":132,"device_name":133,"device_class":8,"k510_count":24},"DLA","Test Reagents For Methyl Alcohol",{"product_code":135,"device_name":136,"device_class":8,"k510_count":24},"DLH","Gas Chromatography, Alcohol",{"product_code":138,"device_name":139,"device_class":8,"k510_count":24},"DLS","Gas Chromatograph, Alcohol (Dedicated Instruments)",{"product_code":141,"device_name":142,"device_class":8,"k510_count":24},"DMJ","Test Reagents For Ethyl Alcohol",{"product_code":144,"device_name":145,"device_class":8,"k510_count":24},"OIC","Blood Alcohol Kit (Excludes Hiv Testing)",{"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","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]