[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LTS":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":99,"syncDates":200,"translation":207,"marketSummary":213,"recalls":228,"k510s":230,"pmas":238},{"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":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":27,"pma_count":28,"event_count":27},1193,"LTS","Test Reagents, Neisseria Gonorrhoeae Biochemical","1","866.2660","MI","Microbiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":21,"product_code":6,"review_panel":10,"gmp_exempt_flag":21,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":21,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":17,"pma_number":19},[18],"K954784",[20],"P770010","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:47.808424+00:00",0,null,1,2,[],[31,39,47,53,60,67,73,80,87,93],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":25,"vector_similarity":37,"score":38},3596,"再使用可能な尖叉試験用針","Ⅰ","15679001",0.142857,0.589973,0.0322665,{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":25,"vector_similarity":45,"score":46},1820,"尖叉試験・ワクチン用針","Ⅱ","15679022",0.111111,0.552111,0.0261613,{"medical_device_id":48,"generic_name":49,"class_classification":34,"jmdn_code":50,"name_similarity":44,"definition_similarity":25,"vector_similarity":51,"score":52},3607,"再使用可能な生検用針","31730000",0.553232,0.0260695,{"medical_device_id":54,"generic_name":55,"class_classification":34,"jmdn_code":56,"name_similarity":57,"definition_similarity":25,"vector_similarity":58,"score":59},3526,"窒素分析装置","36741000",0.047619,0.598491,0.0163934,{"medical_device_id":61,"generic_name":62,"class_classification":42,"jmdn_code":63,"name_similarity":64,"definition_similarity":25,"vector_similarity":65,"score":66},2751,"歯科用色調試験材料","70844000",0.125,0.507269,0.016129,{"medical_device_id":68,"generic_name":69,"class_classification":34,"jmdn_code":70,"name_similarity":71,"definition_similarity":25,"vector_similarity":72,"score":66},3579,"微生物分類同定分析装置","34573000",0.0526316,0.595315,{"medical_device_id":74,"generic_name":75,"class_classification":34,"jmdn_code":76,"name_similarity":77,"definition_similarity":25,"vector_similarity":78,"score":79},3515,"便潜血測定装置","70182000",0.123288,0.516808,0.015873,{"medical_device_id":81,"generic_name":82,"class_classification":34,"jmdn_code":83,"name_similarity":84,"definition_similarity":25,"vector_similarity":85,"score":86},3581,"微生物培養装置","70189000",0.0724638,0.587876,0.015625,{"medical_device_id":88,"generic_name":89,"class_classification":34,"jmdn_code":90,"name_similarity":91,"definition_similarity":25,"vector_similarity":92,"score":86},3774,"再使用可能な外科手術用痔核クランプ","34952000",0.121622,0.481232,{"medical_device_id":94,"generic_name":95,"class_classification":42,"jmdn_code":96,"name_similarity":91,"definition_similarity":25,"vector_similarity":97,"score":98},2752,"歯科用色調適合確認材料","70845000",0.518058,0.0153846,[100,104,108,112,116,120,124,128,132,136,139,143,146,150,154,157,161,164,167,171,174,178,182,185,188,191,194,197],{"product_code":101,"device_name":102,"device_class":8,"k510_count":103},"JTO","Discs, Strips And Reagents, Microorganism Differentiation",244,{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"JSS","Kit, Identification, Enterobacteriaceae",49,{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"JXA","Kit, Screening, Urine",44,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"LIB","Device, General Purpose, Microbiology, Diagnostic",43,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"LLH","Reagents, Clostridium Difficile Toxin",42,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"LJG","Quality Control Slides",27,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"JWX","Kit, Screening, Staphylococcus Aureus",20,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"JSP","Kit, Anaerobic Identification",18,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"JSX","Kit, Identification, Neisseria Gonorrhoeae",16,{"product_code":137,"device_name":138,"device_class":8,"k510_count":135},"JXB","Kit, Identification, Yeast",{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"JWZ","Kit, Screening, Trichomonas",11,{"product_code":144,"device_name":145,"device_class":8,"k510_count":142},"LQL","Gram Positive Identification Panel",{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"MCB","Antigen, C. Difficile",10,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"LQM","Gram Negative Identification Panel",7,{"product_code":155,"device_name":156,"device_class":8,"k510_count":153},"LSC","Neisseria Controls",{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"JST","Kit, Fastidious Organisms",6,{"product_code":162,"device_name":163,"device_class":8,"k510_count":160},"JSW","Kit, Identification, Glucose Nonfermenter",{"product_code":165,"device_name":166,"device_class":8,"k510_count":160},"JXC","Kit, Screening, Yeast",{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"JSY","Kit, Identification, Mycobacteria",5,{"product_code":172,"device_name":173,"device_class":8,"k510_count":170},"OMN","C. Difficile Nucleic Acid Amplification Test Assay",{"product_code":175,"device_name":176,"device_class":8,"k510_count":177},"LRH","Instrument For Auto Reader Of Overnight Microorganism Identification System",4,{"product_code":179,"device_name":180,"device_class":8,"k510_count":181},"NZS","Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast",3,{"product_code":183,"device_name":184,"device_class":8,"k510_count":28},"MJM","Dna Probe, Gardnerella Vaginalis",{"product_code":186,"device_name":187,"device_class":8,"k510_count":28},"MLA","Dna Probe, Yeast",{"product_code":189,"device_name":190,"device_class":8,"k510_count":28},"MXB","Test, Vaginal, Bacterial Sialidase",{"product_code":192,"device_name":193,"device_class":8,"k510_count":27},"JSR","Kit, Identification, Dermatophyte",{"product_code":195,"device_name":196,"device_class":8,"k510_count":27},"JSZ","Kit, Identification, Pseudomonas",{"product_code":198,"device_name":199,"device_class":8,"k510_count":27},"MJK","Dna Probe, Trichomonas Vaginalis",{"510k":201,"classification":202,"enforcement":203,"event":204,"pma":205,"warning_letter":206},"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":208,"definition_ja":26,"commentary_ja":209,"model_name":210,"source_hash":211,"reviewed_by":26,"reviewed_at":26,"created_at":212,"updated_at":212},"淋菌生化学的同定用試薬","本品は、淋菌（Neisseria Gonorrhoeae）を生化学的性状に基づき同定するための試薬です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分に該当します。","claude-sonnet-5","d907146248d725695ba640852dba81ac606c7ac47618819b98c78d010c36466d","2026-08-24T02:13:33.96397+00:00",{"product_code":6,"summary_ja":214,"stats":215,"stats_hash":226,"model_name":210,"created_at":227,"updated_at":227},"510(k)届出は累計1件で、参入企業数は1社、最新の判定は1996年1月です。PMAは本承認の実績がなく、一部変更承認が2件確認されており、最新の判定は1981年11月です。不具合報告は累計1件で、その全てが不具合（Malfunction）によるものであり、死亡・傷害の報告は確認されていません。回収については累計件数が0件で、クラスI・II・IIIのいずれも確認されていません。",{"pma":216,"k510":218,"as_of":220,"events":221,"recalls":223,"top_problems":225},{"latest":217,"originals":25,"supplements":28},"1981-11-19",{"total":27,"last5y":25,"latest":219,"applicants":27},"1996-01-30","2026-08",{"death":25,"other":25,"total":27,"injury":25,"last5y":25,"malfunction":27,"latest_month":222},"1995-07",{"total":25,"last5y":25,"latest":26,"class_i":25,"class_ii":25,"class_iii":25,"top_root_causes":224},[],[],"fa765b679add621cba681bf594dd0c51856e7882e4bec94c2d8a70a71326261d","2026-08-24T04:52:46.442187+00:00",{"items":229,"total":25},[],{"items":231,"total":27},[232],{"k_number":18,"device_name":233,"applicant":234,"decision_date":219,"clearance_type":235,"decision_code":236,"statement_or_summary":237},"DRYSIDE NEISSERIA","Difco Laboratories, Inc.","Traditional","SESE","Summary",{"items":239,"total":28},[240,244],{"pma_number":20,"supplement_number":241,"trade_name":242,"applicant":243,"decision_date":217},"S002","GONODECTEN","Mediserve International, Inc.",{"pma_number":20,"supplement_number":245,"trade_name":242,"applicant":243,"decision_date":246},"S001","1980-06-10"]