[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QWR":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":118,"syncDates":123},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":36,"event_count":37},6356,"QWR","Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings","2","866.3982","MI","Microbiology","1","A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":28,"device_class":8,"implant_flag":29,"product_code":6,"review_panel":10,"gmp_exempt_flag":29,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":28,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":17,"fei_number":21,"registration_number":27},[18,19,20],"K223783","K221925","K243346",[22,23,24,25,26],"3004141078","2243471","3019946577","1221359","3023372670",[22,23,24,25,26],"","N","Ineligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",2,"2025-04-23",3,0,148,[],[40,49,58,66,73,81,88,96,103,111],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3279,"胸部画像診断・放射線治療用患者体位固定具","Ⅰ","40899000",0.135484,0.245536,0.637394,0.0289916,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},3180,"病理ホールスライド画像診断補助装置","Ⅱ","15132012",0.136054,0.206235,0.631581,0.027032,{"medical_device_id":59,"generic_name":60,"class_classification":52,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},1246,"腹部集団検診用X線診断装置","37675010",0.0451613,0.257391,0.653729,0.0163934,{"medical_device_id":67,"generic_name":68,"class_classification":52,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":65},2992,"患者適合型単回使用関節手術用器械","70964212",0.180451,0.193548,0.504686,{"medical_device_id":74,"generic_name":75,"class_classification":52,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},1278,"核医学診断用検出器回転型SPECT装置","40642000",0.160305,0.256897,0.600821,0.016129,{"medical_device_id":82,"generic_name":83,"class_classification":43,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":80},3376,"呼気ガスディテクタ","70087000",0.0569106,0.178241,0.653316,{"medical_device_id":89,"generic_name":90,"class_classification":52,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},1248,"胸部集団検診用X線診断装置","37627010",0.0457516,0.251701,0.651044,0.015873,{"medical_device_id":97,"generic_name":98,"class_classification":52,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":95},3000,"患者適合型単回使用骨手術用器械","70962212",0.162963,0.181598,0.52977,{"medical_device_id":104,"generic_name":105,"class_classification":52,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110},1250,"胸・腹部集団検診用X線診断装置","37627030",0.054878,0.258706,0.649435,0.015625,{"medical_device_id":112,"generic_name":113,"class_classification":43,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":110},3278,"頭頸部画像診断・放射線治療用患者体位固定具","40898000",0.147436,0.262156,0.592736,[119],{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"QVF","Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings",9,{"510k":124,"classification":125,"enforcement":126,"event":127,"pma":128,"warning_letter":129},"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"]