[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MSV":3},{"classification":4,"mappedDevices":102,"similarCandidates":103,"relatedClassifications":175,"syncDates":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":96,"updated_at":97,"recall_count":98,"latest_recall_date":99,"k510_count":100,"pma_count":101,"event_count":101},3773,"MSV","System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)","2","866.5660","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":93,"product_code":6,"review_panel":10,"gmp_exempt_flag":93,"third_party_flag":94,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":93,"medical_specialty_description":11,"summary_malfunction_reporting":95},{"k_number":17,"fei_number":64,"registration_number":84},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"K991804","K152875","K013956","K991801","K973882","K040450","K991803","K013080","K020695","K091556","K980230","K973014","K030702","K021611","K040449","K992224","K031177","K243979","K992243","K141274","K982879","K013077","K072032","K040452","K022944","K982433","K992241","K021610","K040451","K030397","K112414","K013628","K991802","K162788","K062217","K973006","K970551","K030701","K092757","K013079","K982434","K972790","K181329","K982391","K031208","K022945",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"3002806557","3005774014","1832216","1217183","1000117401","3002807876","3002808269","1421346","3012348571","1000305932","1181055","3037000637","2026994","3039353646","1000121039","3004973408","2915274","3002701146","3003825930",[67,85,68,86,72,73,87,88,75,89,76,77,90,78,91,92,80,81,83],"9680745","1222302","1721937","3032705","9610566","9610746","8043792","1529254","N","Y","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",1,null,46,0,[],[104,112,120,128,135,142,148,155,162,168],{"medical_device_id":105,"generic_name":106,"class_classification":107,"jmdn_code":108,"name_similarity":109,"definition_similarity":101,"vector_similarity":110,"score":111},1808,"健康検診システム","Ⅱ","70178000",0.164179,0.641211,0.0310544,{"medical_device_id":113,"generic_name":114,"class_classification":115,"jmdn_code":116,"name_similarity":117,"definition_similarity":101,"vector_similarity":118,"score":119},3504,"蛋白質分析装置","Ⅰ","30857000",0.150943,0.627181,0.0290099,{"medical_device_id":121,"generic_name":122,"class_classification":123,"jmdn_code":124,"name_similarity":125,"definition_similarity":101,"vector_similarity":126,"score":127},1071,"グルコースモニタシステム","Ⅲ","44611003",0.155172,0.600702,0.0261207,{"medical_device_id":129,"generic_name":130,"class_classification":123,"jmdn_code":131,"name_similarity":132,"definition_similarity":101,"vector_similarity":133,"score":134},1157,"遺伝子変異解析システム（がんゲノムプロファイリング検査用）","60943033",0.137931,0.621904,0.0258492,{"medical_device_id":136,"generic_name":137,"class_classification":107,"jmdn_code":138,"name_similarity":139,"definition_similarity":101,"vector_similarity":140,"score":141},1624,"定量的感覚検査用温度分析装置","37350000",0.210526,0.569456,0.0163934,{"medical_device_id":143,"generic_name":144,"class_classification":115,"jmdn_code":145,"name_similarity":146,"definition_similarity":101,"vector_similarity":147,"score":141},3523,"グリコヘモグロビン分析装置","35968000",0.131148,0.651845,{"medical_device_id":149,"generic_name":150,"class_classification":123,"jmdn_code":151,"name_similarity":152,"definition_similarity":101,"vector_similarity":153,"score":154},788,"麻酔システム","37710000",0.188679,0.508003,0.016129,{"medical_device_id":156,"generic_name":157,"class_classification":123,"jmdn_code":158,"name_similarity":159,"definition_similarity":101,"vector_similarity":160,"score":161},1140,"体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用）","71059003",0.111111,0.640892,0.015873,{"medical_device_id":163,"generic_name":164,"class_classification":107,"jmdn_code":165,"name_similarity":166,"definition_similarity":101,"vector_similarity":167,"score":161},2388,"腹水濾過濃縮用血液回路","70550000",0.17284,0.521375,{"medical_device_id":169,"generic_name":170,"class_classification":123,"jmdn_code":171,"name_similarity":172,"definition_similarity":101,"vector_similarity":173,"score":174},763,"腹水濾過濃縮用装置","70543000",0.171429,0.531867,0.015625,[176,180,184,188,192,196,200,204,207,210,213,217,220,223,226,229,232,235],{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"MID","System, Test, Anticardiolipin Immunological",94,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"MOB","Test System, Antineutrophil Cytoplasmic Antibodies (Anca)",74,{"product_code":185,"device_name":186,"device_class":8,"k510_count":187},"MVM","Autoantibodies, Endomysial(Tissue Transglutaminase)",40,{"product_code":189,"device_name":190,"device_class":8,"k510_count":191},"DBL","Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control",24,{"product_code":193,"device_name":194,"device_class":8,"k510_count":195},"MVJ","Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)",6,{"product_code":197,"device_name":198,"device_class":8,"k510_count":199},"NST","Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking",4,{"product_code":201,"device_name":202,"device_class":8,"k510_count":203},"NBS","Autoantibodies, Lkm-1 (Liver\u002FKidney Microsome, Type 1)",3,{"product_code":205,"device_name":206,"device_class":8,"k510_count":203},"NIY","Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis",{"product_code":208,"device_name":209,"device_class":8,"k510_count":203},"OEG","Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230",{"product_code":211,"device_name":212,"device_class":8,"k510_count":203},"OIF","Tyrosine Phosphatase (Ia-2) Autoantibody Assay",{"product_code":214,"device_name":215,"device_class":8,"k510_count":216},"NBO","Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)",2,{"product_code":218,"device_name":219,"device_class":8,"k510_count":216},"NWG","Autoantibodies, Glutamic Acid Decarboxylase (Gad)",{"product_code":221,"device_name":222,"device_class":8,"k510_count":216},"PCG","21-Hydroxylase Antibody (21-Ohab)",{"product_code":224,"device_name":225,"device_class":8,"k510_count":98},"MVS","Kit, Typing, Hla-Dqb",{"product_code":227,"device_name":228,"device_class":8,"k510_count":98},"OCN","Insulin Autoantibody Kit",{"product_code":230,"device_name":231,"device_class":8,"k510_count":98},"OPN","Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine\u002FProthrombin Complex",{"product_code":233,"device_name":234,"device_class":8,"k510_count":98},"OSK","Anti-Glutamate Receptor (Type Nmda) Ifa",{"product_code":236,"device_name":237,"device_class":8,"k510_count":98},"PAF","Voltage Gated  Calcium Channel (Vgcc) Antibody Assay",{"510k":239,"classification":240,"enforcement":241,"event":242,"pma":243,"warning_letter":244},"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"]