[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PCH":3},{"classification":4,"mappedDevices":86,"similarCandidates":87,"relatedClassifications":166,"syncDates":175},{"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":79,"updated_at":80,"recall_count":81,"latest_recall_date":82,"k510_count":83,"pma_count":84,"event_count":85},5719,"PCH","Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System","2","866.3990","MI","Microbiology","1","A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and\u002For symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":76,"device_class":8,"implant_flag":77,"product_code":6,"review_panel":10,"gmp_exempt_flag":77,"third_party_flag":77,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":76,"life_sustain_support_flag":77,"medical_specialty_description":11,"summary_malfunction_reporting":78},{"k_number":17,"fei_number":56,"registration_number":73},[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],"K230404","K152955","K252329","K251868","K140647","K143648","K180041","K243813","K220193","K254032","K181427","K220607","K251993","K190585","K191161","K191160","K182703","K242367","K142033","K243885","K251721","DEN130003","K121894","K160459","K142501","K183023","K232672","K123274","K250324","K140083","K140377","K220062","K253722","K140407","K143005","K183030","K170308","K242877",[57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"3002524000","3004530258","3005670738","3014553740","3006028115","3004013603","3007799234","3007420875","3011781554","2024800","3016838963","1119779","3009613136","3002773840","3010749841","3002777243",[58,60,61,62,74,63,64,65,66,75,67,68,69,70,71,72],"1650733","3005360469","","N","Ineligible","2026-08-18T05:52:52.949882+00:00","2026-08-19T02:30:42.714273+00:00",24,"2025-12-10",38,0,256,[],[88,97,105,113,120,129,136,144,151,159],{"medical_device_id":89,"generic_name":90,"class_classification":91,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":96},1247,"腹部集団検診用一体型X線診断装置","Ⅱ","37675020",0.144068,0.285437,0.663394,0.0274254,{"medical_device_id":98,"generic_name":99,"class_classification":91,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},1251,"胸・腹部集団検診用一体型X線診断装置","37627040",0.149606,0.290203,0.640405,0.027027,{"medical_device_id":106,"generic_name":107,"class_classification":91,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},1250,"胸・腹部集団検診用X線診断装置","37627030",0.140496,0.280148,0.633383,0.023823,{"medical_device_id":114,"generic_name":115,"class_classification":91,"jmdn_code":116,"name_similarity":101,"definition_similarity":117,"vector_similarity":118,"score":119},1220,"移動型アナログ式汎用一体型X線透視診断装置","37622020",0.233716,0.627056,0.0234311,{"medical_device_id":121,"generic_name":122,"class_classification":123,"jmdn_code":124,"name_similarity":125,"definition_similarity":126,"vector_similarity":127,"score":128},3579,"微生物分類同定分析装置","Ⅰ","34573000",0.03,0.236318,0.706314,0.0163934,{"medical_device_id":130,"generic_name":131,"class_classification":123,"jmdn_code":132,"name_similarity":133,"definition_similarity":134,"vector_similarity":135,"score":128},4375,"消化器用サイザ","70971000",0.236842,0.146032,0.612183,{"medical_device_id":137,"generic_name":138,"class_classification":91,"jmdn_code":139,"name_similarity":140,"definition_similarity":141,"vector_similarity":142,"score":143},2092,"経腸栄養ポンプ用消化器用ストップコック","35375032",0.216495,0.201705,0.575349,0.016129,{"medical_device_id":145,"generic_name":146,"class_classification":123,"jmdn_code":147,"name_similarity":148,"definition_similarity":149,"vector_similarity":150,"score":143},3536,"微生物由来成分分析装置","70183000",0.0416667,0.126126,0.688105,{"medical_device_id":152,"generic_name":153,"class_classification":91,"jmdn_code":154,"name_similarity":155,"definition_similarity":156,"vector_similarity":157,"score":158},1903,"消化管用チューブ","14202000",0.223684,0.141593,0.591689,0.015873,{"medical_device_id":160,"generic_name":161,"class_classification":123,"jmdn_code":162,"name_similarity":163,"definition_similarity":164,"vector_similarity":165,"score":158},3591,"遺伝子解析装置","70192000",0.0493827,0.205797,0.679068,[167,171],{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"PCI","Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System",5,{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"PIQ","Reagents For Detection Of Norovirus Nucleic Acid",1,{"510k":176,"classification":177,"enforcement":178,"event":179,"pma":180,"warning_letter":181},"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"]