[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NJT":3},{"classification":4,"mappedDevices":81,"similarCandidates":82,"relatedClassifications":163,"syncDates":226},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":75,"updated_at":76,"recall_count":77,"latest_recall_date":78,"k510_count":79,"pma_count":79,"event_count":80},1567,"NJT","Immunohistochemistry Reagents And Kits","1","864.1860","HE","Hematology","PA","4","according to the regs...\"..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":72,"device_class":8,"implant_flag":73,"product_code":6,"review_panel":12,"gmp_exempt_flag":73,"third_party_flag":73,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":72,"life_sustain_support_flag":73,"medical_specialty_description":11,"summary_malfunction_reporting":74},{"fei_number":18,"registration_number":64},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"3009963993","2022180","3000718726","3014429566","3017212430","1000125183","3006461677","3007035884","3013059683","3015258926","3027582128","3010939897","3017170972","1640981","3008505743","3003741796","3004140393","3003335080","3005592623","2914537","3017439370","3003423869","3017379203","3010890428","3042159574","3042585783","2936532","3004859032","3010139432","3009189893","3008773547","2083544","3002806560","3014165737","3015614371","1831638","3016764932","3002806778","3012214605","3004074729","2916205","3030509363","3013043616","3002806559","3008174888",[19,20,22,23,26,65,27,66,67,28,29,30,31,32,33,34,35,36,37,68,69,38,39,70,40,41,42,43,44,46,47,48,49,52,71,53,54,55,58,57,59,60,61,50,63],"9610099","3008776165","9610529","1649339","8020030","9610126","2028492","","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",92,"2025-12-10",0,49,[],[83,92,100,108,116,124,132,140,148,155],{"medical_device_id":84,"generic_name":85,"class_classification":86,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},3510,"免疫蛍光分析装置","Ⅰ","35707010",0.163636,0.134185,0.641862,0.0282587,{"medical_device_id":93,"generic_name":94,"class_classification":86,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},3629,"再使用可能な羊水穿刺キット","32685000",0.122807,0.142857,0.644027,0.0259371,{"medical_device_id":101,"generic_name":102,"class_classification":86,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},3508,"免疫比濁分析装置","35926010",0.137931,0.161994,0.631861,0.0257937,{"medical_device_id":109,"generic_name":110,"class_classification":86,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},3511,"移動式免疫蛍光分析装置","35707020",0.145161,0.143791,0.628071,0.0256494,{"medical_device_id":117,"generic_name":118,"class_classification":86,"jmdn_code":119,"name_similarity":120,"definition_similarity":121,"vector_similarity":122,"score":123},3509,"移動式免疫比濁分析装置","35926020",0.123077,0.164038,0.636602,0.0253165,{"medical_device_id":125,"generic_name":126,"class_classification":86,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":131},3514,"粒子計測免疫測定装置","70181000",0.117647,0.171806,0.629806,0.0233926,{"medical_device_id":133,"generic_name":134,"class_classification":86,"jmdn_code":135,"name_similarity":136,"definition_similarity":137,"vector_similarity":138,"score":139},3621,"再使用可能な関節造影キット","15316001",0.109091,0.16087,0.633189,0.0231593,{"medical_device_id":141,"generic_name":142,"class_classification":86,"jmdn_code":143,"name_similarity":144,"definition_similarity":145,"vector_similarity":146,"score":147},3512,"免疫発光測定装置","36223010",0.190476,0.172297,0.609019,0.0163934,{"medical_device_id":149,"generic_name":150,"class_classification":86,"jmdn_code":151,"name_similarity":152,"definition_similarity":153,"vector_similarity":154,"score":147},3588,"自動染色装置","70191000",0.016129,0.179487,0.708831,{"medical_device_id":156,"generic_name":157,"class_classification":158,"jmdn_code":159,"name_similarity":160,"definition_similarity":161,"vector_similarity":162,"score":152},1868,"骨髄生検キット","Ⅱ","16833000",0.0535714,0.152838,0.685938,[164,169,173,176,180,184,188,192,195,199,202,205,208,211,214,217,220,223],{"product_code":165,"device_name":166,"device_class":167,"k510_count":168},"NQN","Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity","2",15,{"product_code":170,"device_name":171,"device_class":167,"k510_count":172},"MXZ","Immunohistochemistry Assay, Antibody, Progesterone Receptor",13,{"product_code":174,"device_name":175,"device_class":167,"k510_count":172},"NOT","Microscope, Automated, Image Analysis, Operator Intervention",{"product_code":177,"device_name":178,"device_class":167,"k510_count":179},"MYA","Immunohistochemistry Antibody Assay, Estrogen Receptor",12,{"product_code":181,"device_name":182,"device_class":167,"k510_count":183},"OEO","Automated Digital Image Manual Interpretation Microscope",6,{"product_code":185,"device_name":186,"device_class":167,"k510_count":187},"NJW","Control Material, Her-2\u002FNeu, Immunohistochemistry",2,{"product_code":189,"device_name":190,"device_class":167,"k510_count":191},"NBK","System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer",1,{"product_code":193,"device_name":194,"device_class":8,"k510_count":191},"NTR","Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells",{"product_code":196,"device_name":197,"device_class":198,"k510_count":79},"LPI","Kit, Assay, Progesterone Receptor","3",{"product_code":200,"device_name":201,"device_class":198,"k510_count":79},"LPJ","Kit, Assay, Estrogen Receptor",{"product_code":203,"device_name":204,"device_class":198,"k510_count":79},"NKF","Immunohistochemistry Antibody Assay, C-Kit",{"product_code":206,"device_name":207,"device_class":198,"k510_count":79},"NQF","Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor",{"product_code":209,"device_name":210,"device_class":198,"k510_count":79},"QKF","Immunocytochemistry Assay, P16\u002FKi-67",{"product_code":212,"device_name":213,"device_class":198,"k510_count":79},"QNH","Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay",{"product_code":215,"device_name":216,"device_class":198,"k510_count":79},"QUL","Immunohistochemistry Assay, Antibody, Folr1",{"product_code":218,"device_name":219,"device_class":198,"k510_count":79},"QZJ","Immunohistochemistry Assay, Antibody, Claudin 18",{"product_code":221,"device_name":222,"device_class":198,"k510_count":79},"SBL","Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4",{"product_code":224,"device_name":225,"device_class":198,"k510_count":79},"SER","Immunohistochemistry Assay, Antibody, Met",{"510k":227,"classification":228,"enforcement":229,"event":230,"pma":231,"warning_letter":232},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]