[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MVW":3},{"classification":4,"mappedDevices":23,"similarCandidates":24,"relatedClassifications":96,"syncDates":97,"translation":104,"marketSummary":110,"recalls":125,"k510s":127,"pmas":129},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":18,"updated_at":19,"recall_count":20,"latest_recall_date":21,"k510_count":20,"pma_count":20,"event_count":22},4004,"MVW","Kit, Western Blot, Hiv-1","N","","Unknown","HE","3",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":8,"product_code":6,"review_panel":11,"gmp_exempt_flag":8,"third_party_flag":8,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":16,"life_sustain_support_flag":8,"medical_specialty_description":10,"summary_malfunction_reporting":17},{},"4","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:47.808424+00:00",0,null,6,[],[25,33,40,47,54,60,68,75,82,89],{"medical_device_id":26,"generic_name":27,"class_classification":28,"jmdn_code":29,"name_similarity":30,"definition_similarity":20,"vector_similarity":31,"score":32},2152,"動脈採血キット","Ⅱ","31336000",0.186047,0.631936,0.0325225,{"medical_device_id":34,"generic_name":35,"class_classification":28,"jmdn_code":36,"name_similarity":37,"definition_similarity":20,"vector_similarity":38,"score":39},2154,"胎児用頭皮採血キット","16873000",0.152174,0.627261,0.03125,{"medical_device_id":41,"generic_name":42,"class_classification":28,"jmdn_code":43,"name_similarity":44,"definition_similarity":20,"vector_similarity":45,"score":46},1869,"腎臓生検キット","16834000",0.142857,0.631479,0.0302135,{"medical_device_id":48,"generic_name":49,"class_classification":28,"jmdn_code":50,"name_similarity":51,"definition_similarity":20,"vector_similarity":52,"score":53},1874,"肺生検キット","38562000",0.147059,0.621011,0.0298507,{"medical_device_id":55,"generic_name":56,"class_classification":28,"jmdn_code":57,"name_similarity":51,"definition_similarity":20,"vector_similarity":58,"score":59},1875,"脳生検キット","38563000",0.611166,0.0289916,{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":20,"vector_similarity":66,"score":67},1082,"血液成分分離キット","Ⅲ","58331003",0.148936,0.585644,0.0274328,{"medical_device_id":69,"generic_name":70,"class_classification":28,"jmdn_code":71,"name_similarity":72,"definition_similarity":20,"vector_similarity":73,"score":74},1868,"骨髄生検キット","16833000",0.125,0.616259,0.0266879,{"medical_device_id":76,"generic_name":77,"class_classification":28,"jmdn_code":78,"name_similarity":79,"definition_similarity":20,"vector_similarity":80,"score":81},2198,"産科用麻酔キット","33595000",0.139535,0.580093,0.0249346,{"medical_device_id":83,"generic_name":84,"class_classification":28,"jmdn_code":85,"name_similarity":86,"definition_similarity":20,"vector_similarity":87,"score":88},1721,"腎盂鏡検査キット","32083000",0.117647,0.594445,0.0245693,{"medical_device_id":90,"generic_name":91,"class_classification":28,"jmdn_code":92,"name_similarity":93,"definition_similarity":20,"vector_similarity":94,"score":95},1871,"軟組織生検キット","16835010",0.121951,0.590422,0.0241525,[],{"510k":98,"classification":99,"enforcement":100,"event":101,"pma":102,"warning_letter":103},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":105,"definition_ja":21,"commentary_ja":106,"model_name":107,"source_hash":108,"reviewed_by":21,"reviewed_at":21,"created_at":109,"updated_at":109},"HIV-1ウエスタンブロットキット","この製品は、米国FDAの分類データベースにおいて分類対象外とされており、明確なデバイスクラスや規制区分が付与されていない機器です。このような場合、市販前届出（510(k)）や市販前承認（PMA）のいずれの審査区分に該当するかはあらかじめ定められておらず、個別にFDAの担当部門（ODE）へ照会して判断を仰ぐ必要があるとされています。","claude-sonnet-5","ebf19132894652ebf8bb23011d49c73a075e724dea349e87e69b9185e9f1d510","2026-08-24T02:14:44.518901+00:00",{"product_code":6,"summary_ja":111,"stats":112,"stats_hash":123,"model_name":107,"created_at":124,"updated_at":124},"510(k)およびPMAの累計件数はいずれも確認されていません。不具合報告は累計6件で、死亡・傷害の報告はなく、不具傷（Malfunction）が2件、その他が4件となっており、直近5年间の報告はありません。最新の報告月は2008年11月です。回収については累計・直近5年ともに確認されていません。",{"pma":113,"k510":114,"as_of":115,"events":116,"recalls":120,"top_problems":122},{"latest":21,"originals":20,"supplements":20},{"total":20,"last5y":20,"latest":21,"applicants":20},"2026-08",{"death":20,"other":117,"total":22,"injury":20,"last5y":20,"malfunction":118,"latest_month":119},4,2,"2008-11",{"total":20,"last5y":20,"latest":21,"class_i":20,"class_ii":20,"class_iii":20,"top_root_causes":121},[],[],"21d071a281c77b531ad3f3fe8d0f268b35857baec160a0cfb39964a2136137ab","2026-08-24T04:57:04.90455+00:00",{"items":126,"total":20},[],{"items":128,"total":20},[],{"items":130,"total":20},[]]