[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JSX":3},{"classification":4,"mappedDevices":56,"similarCandidates":57,"relatedClassifications":133,"syncDates":232},{"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":49,"updated_at":50,"recall_count":51,"latest_recall_date":52,"k510_count":53,"pma_count":54,"event_count":55},3637,"JSX","Kit, Identification, Neisseria Gonorrhoeae","1","866.2660","MI","Microbiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":47,"product_code":6,"review_panel":10,"gmp_exempt_flag":47,"third_party_flag":47,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":47,"medical_specialty_description":11,"summary_malfunction_reporting":48},{"k_number":17,"fei_number":34,"pma_number":41,"registration_number":44},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"K960759","K870117","K781108","K913456","K811412","K923566","K782013","K852582","K833307","K853544","K812048","K881501","K833180","K852998","K880511","K830364",[35,36,37,38,39,40],"3016837106","3003952975","1924669","3003750284","3026312356","1000306617",[42,43],"N17985","P770002",[45,35,37,38,46,39],"2032682","2029372","N","Ineligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",1,"2025-12-10",16,3,2,[],[58,67,75,82,90,97,104,111,119,126],{"medical_device_id":59,"generic_name":60,"class_classification":61,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},3579,"微生物分類同定分析装置","Ⅰ","34573000",0.280702,0,0.631014,0.0320184,{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":64,"vector_similarity":73,"score":74},1986,"間欠泌尿器用カテーテルイントロデューサキット","Ⅱ","16321000",0.183099,0.606464,0.0301178,{"medical_device_id":76,"generic_name":77,"class_classification":70,"jmdn_code":78,"name_similarity":79,"definition_similarity":64,"vector_similarity":80,"score":81},1988,"泌尿器用カテーテルイントロデューサキット","32030000",0.180328,0.598752,0.029236,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":64,"vector_similarity":88,"score":89},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",0.157895,0.636327,0.028629,{"medical_device_id":91,"generic_name":92,"class_classification":70,"jmdn_code":93,"name_similarity":94,"definition_similarity":64,"vector_similarity":95,"score":96},1938,"吸引キット","13846000",0.152174,0.631029,0.0276377,{"medical_device_id":98,"generic_name":99,"class_classification":70,"jmdn_code":100,"name_similarity":101,"definition_similarity":64,"vector_similarity":102,"score":103},1985,"泌尿器用カテーテル挿入・採尿キット","14292000",0.142857,0.640464,0.0276294,{"medical_device_id":105,"generic_name":106,"class_classification":85,"jmdn_code":107,"name_similarity":108,"definition_similarity":64,"vector_similarity":109,"score":110},31,"中心静脈用カテーテルイントロデューサキット","16615110",0.171875,0.584232,0.0262346,{"medical_device_id":112,"generic_name":113,"class_classification":114,"jmdn_code":115,"name_similarity":116,"definition_similarity":64,"vector_similarity":117,"score":118},688,"植込み型病変識別マーカ","Ⅲ","40808000",0.234375,0.518412,0.016129,{"medical_device_id":120,"generic_name":121,"class_classification":70,"jmdn_code":122,"name_similarity":123,"definition_similarity":64,"vector_similarity":124,"score":125},2807,"歯科用印象材キット","70886000",0.183333,0.546252,0.015873,{"medical_device_id":127,"generic_name":128,"class_classification":70,"jmdn_code":129,"name_similarity":130,"definition_similarity":64,"vector_similarity":131,"score":132},1870,"子宮内組織採取キット","11531000",0.0819672,0.613106,0.0153846,[134,138,142,146,150,154,158,162,166,169,173,176,180,184,187,191,194,197,201,204,208,211,214,217,220,223,226,229],{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"JTO","Discs, Strips And Reagents, Microorganism Differentiation",244,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"JSS","Kit, Identification, Enterobacteriaceae",49,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"JXA","Kit, Screening, Urine",44,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"LIB","Device, General Purpose, Microbiology, Diagnostic",43,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"LLH","Reagents, Clostridium Difficile Toxin",42,{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"LJG","Quality Control Slides",27,{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"JWX","Kit, Screening, Staphylococcus Aureus",20,{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"JSP","Kit, Anaerobic Identification",18,{"product_code":167,"device_name":168,"device_class":8,"k510_count":53},"JXB","Kit, Identification, Yeast",{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"JWZ","Kit, Screening, Trichomonas",11,{"product_code":174,"device_name":175,"device_class":8,"k510_count":172},"LQL","Gram Positive Identification Panel",{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"MCB","Antigen, C. Difficile",10,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"LQM","Gram Negative Identification Panel",7,{"product_code":185,"device_name":186,"device_class":8,"k510_count":183},"LSC","Neisseria Controls",{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"JST","Kit, Fastidious Organisms",6,{"product_code":192,"device_name":193,"device_class":8,"k510_count":190},"JSW","Kit, Identification, Glucose Nonfermenter",{"product_code":195,"device_name":196,"device_class":8,"k510_count":190},"JXC","Kit, Screening, Yeast",{"product_code":198,"device_name":199,"device_class":8,"k510_count":200},"JSY","Kit, Identification, Mycobacteria",5,{"product_code":202,"device_name":203,"device_class":8,"k510_count":200},"OMN","C. Difficile Nucleic Acid Amplification Test Assay",{"product_code":205,"device_name":206,"device_class":8,"k510_count":207},"LRH","Instrument For Auto Reader Of Overnight Microorganism Identification System",4,{"product_code":209,"device_name":210,"device_class":8,"k510_count":54},"NZS","Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast",{"product_code":212,"device_name":213,"device_class":8,"k510_count":55},"MJM","Dna Probe, Gardnerella Vaginalis",{"product_code":215,"device_name":216,"device_class":8,"k510_count":55},"MLA","Dna Probe, Yeast",{"product_code":218,"device_name":219,"device_class":8,"k510_count":55},"MXB","Test, Vaginal, Bacterial Sialidase",{"product_code":221,"device_name":222,"device_class":8,"k510_count":51},"JSR","Kit, Identification, Dermatophyte",{"product_code":224,"device_name":225,"device_class":8,"k510_count":51},"JSZ","Kit, Identification, Pseudomonas",{"product_code":227,"device_name":228,"device_class":8,"k510_count":51},"LTS","Test Reagents, Neisseria Gonorrhoeae Biochemical",{"product_code":230,"device_name":231,"device_class":8,"k510_count":51},"MJK","Dna Probe, Trichomonas Vaginalis",{"510k":233,"classification":234,"enforcement":235,"event":236,"pma":237,"warning_letter":238},"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"]