[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GQQ":3},{"classification":4,"mappedDevices":26,"similarCandidates":27,"relatedClassifications":100,"syncDates":119,"translation":126,"marketSummary":132,"recalls":145,"k510s":147,"pmas":154},{"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":21,"updated_at":22,"recall_count":23,"latest_recall_date":24,"k510_count":25,"pma_count":23,"event_count":23},2573,"GQQ","Antisera, Hai, Parainfluenza Virus 1-4","1","866.3400","MI","Microbiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":20},{"k_number":17},[18],"K780007","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:48.758894+00:00",0,null,1,[],[28,36,44,51,59,67,74,80,87,93],{"medical_device_id":29,"generic_name":30,"class_classification":31,"jmdn_code":32,"name_similarity":33,"definition_similarity":23,"vector_similarity":34,"score":35},3514,"粒子計測免疫測定装置","Ⅰ","70181000",0.101449,0.538471,0.0285948,{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":23,"vector_similarity":42,"score":43},2206,"子宮頸管傍麻酔キット","Ⅱ","42325000",0.1,0.537139,0.0277831,{"medical_device_id":45,"generic_name":46,"class_classification":31,"jmdn_code":47,"name_similarity":48,"definition_similarity":23,"vector_similarity":49,"score":50},3580,"微生物感受性分析装置","34574000",0.0793651,0.54868,0.0277778,{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":23,"vector_similarity":57,"score":58},681,"消化管用逆流防止補綴材","Ⅲ","35695000",0.0857143,0.526982,0.0246521,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":23,"vector_similarity":65,"score":66},34,"抗菌作用中心静脈用カテーテルイントロデューサキット","Ⅳ","16615400",0.0769231,0.533882,0.0246246,{"medical_device_id":68,"generic_name":69,"class_classification":62,"jmdn_code":70,"name_similarity":71,"definition_similarity":23,"vector_similarity":72,"score":73},293,"発作防止用脳電気刺激装置","36222000",0.115942,0.463506,0.0163934,{"medical_device_id":75,"generic_name":76,"class_classification":39,"jmdn_code":77,"name_similarity":78,"definition_similarity":23,"vector_similarity":79,"score":73},2193,"機械式針なし医薬品・ワクチン用注入器","18069000",0.019802,0.564299,{"medical_device_id":81,"generic_name":82,"class_classification":54,"jmdn_code":83,"name_similarity":84,"definition_similarity":23,"vector_similarity":85,"score":86},504,"穿刺部保護パッチ","70432000",0.0338983,0.548818,0.016129,{"medical_device_id":88,"generic_name":89,"class_classification":39,"jmdn_code":90,"name_similarity":91,"definition_similarity":23,"vector_similarity":92,"score":86},2521,"能動型手用他動運動訓練装置","17137002",0.107692,0.437529,{"medical_device_id":94,"generic_name":95,"class_classification":62,"jmdn_code":96,"name_similarity":97,"definition_similarity":23,"vector_similarity":98,"score":99},299,"抗発作用迷走神経電気刺激装置","34210000",0.106667,0.504058,0.015873,[101,105,109,113,116],{"product_code":102,"device_name":103,"device_class":8,"k510_count":104},"GQS","Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4",11,{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"GQT","Antisera, Cf, Parainfluenza Virus 1-4",4,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"GQP","Antisera, Neutralization, Parainfluenza Virus 1-4",2,{"product_code":114,"device_name":115,"device_class":8,"k510_count":25},"GQR","Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4",{"product_code":117,"device_name":118,"device_class":8,"k510_count":23},"NHZ","Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus",{"510k":120,"classification":121,"enforcement":122,"event":123,"pma":124,"warning_letter":125},"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":127,"definition_ja":24,"commentary_ja":128,"model_name":129,"source_hash":130,"reviewed_by":24,"reviewed_at":24,"created_at":131,"updated_at":131},"パラインフルエンザウイルス1-4型赤血球凝集抑制抗血清","本品は米国FDAの分類でクラスIに区分される体外診断用の抗血清であり、市販前届出（510(k)）が免除されている医療機器です。クラスIは一般に人体へのリスクが低いとされる機器区分であり、510(k)の届出義務がなくても一般的な規制要件（品質システム規制の遵守や機器登録など）は適用されます。","claude-sonnet-5","284791eaf8642e3c281b6a7c83a6541d805a3d1fddde97493451194679b9c158","2026-08-24T01:53:33.449047+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":143,"model_name":129,"created_at":144,"updated_at":144},"本品目はクラス Iで届出免除の区分にあり、510(k)は累計1件、参入企業数は1社にとどまり、直近5年の届出は確認されていません。不具合報告（MDR）については累計報告件数が0件であり、報告は確認されていません。回収についても累計件数は0件で、クラスI・II・IIIいずれの区分でも該当がなく、直近5年の実績も確認されていません。",{"pma":135,"k510":136,"as_of":138,"events":139,"recalls":140,"top_problems":142},{"latest":24,"originals":23,"supplements":23},{"total":25,"last5y":23,"latest":137,"applicants":25},"1978-01-20","2026-08",{"death":23,"other":23,"total":23,"injury":23,"last5y":23,"malfunction":23,"latest_month":24},{"total":23,"last5y":23,"latest":24,"class_i":23,"class_ii":23,"class_iii":23,"top_root_causes":141},[],[],"25502be59c7b4789692613405528344139d497a86a11b21c712faca4c1e7c23c","2026-08-24T04:26:51.412735+00:00",{"items":146,"total":23},[],{"items":148,"total":25},[149],{"k_number":18,"device_name":150,"applicant":151,"decision_date":137,"clearance_type":152,"decision_code":153,"statement_or_summary":24},"GOAT ANTI-INFLUENZA ANTISERA","Northeast Biomedical Labs., Inc.","Traditional","SESE",{"items":155,"total":23},[]]