[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OEP":3},{"classification":4,"mappedDevices":42,"similarCandidates":43,"relatedClassifications":44,"syncDates":79},{"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":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":39,"event_count":39},5808,"OEP","Influenza A Virus Subtype Differentiation Nucleic Acid Assay","2","866.3980","MI","Microbiology","1","A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture.  Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses.  Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":34,"device_class":8,"implant_flag":35,"product_code":6,"review_panel":10,"gmp_exempt_flag":35,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":34,"life_sustain_support_flag":35,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":19,"registration_number":31},[18],"K140851",[20,21,22,23,24,25,26,27,28,29,30],"3002524000","3013019728","3005670738","3006028115","3038610665","3008632402","3007799234","3003030793","3006198300","3002773840","3002777243",[21,23,32,24,25,26,33,27,28,29,30],"1650733","3005360469","","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[],[45,49,53,57,61,65,69,73,76],{"product_code":46,"device_name":47,"device_class":8,"k510_count":48},"OCC","Respiratory Virus Panel Nucleic Acid Assay System",79,{"product_code":50,"device_name":51,"device_class":8,"k510_count":52},"OZE","Influenza A And Influenza B Multiplex Nucleic Acid Assay",20,{"product_code":54,"device_name":55,"device_class":8,"k510_count":56},"OZZ","Bordetella Pertussis Dna Assay System",9,{"product_code":58,"device_name":59,"device_class":8,"k510_count":60},"OEM","Human Metapneumovirus (Hmpv) Rna Assay System",6,{"product_code":62,"device_name":63,"device_class":8,"k510_count":64},"OOU","Parainfluenza Multiplex Nucleic Acid Assay",5,{"product_code":66,"device_name":67,"device_class":8,"k510_count":68},"OMG","Antisera, Fluorescent, Human Metapneumovirus",4,{"product_code":70,"device_name":71,"device_class":8,"k510_count":72},"OZX","Mycoplasma Pneumoniae Dna Assay System",3,{"product_code":74,"device_name":75,"device_class":8,"k510_count":39},"OTG","Non-Sars Coronavirus Multiplex Nucleic Acid Assay",{"product_code":77,"device_name":78,"device_class":8,"k510_count":39},"OZY","Chlamydophila Pneumoniae Dna Assay System",{"510k":80,"classification":81,"enforcement":82,"event":83,"pma":84,"warning_letter":85},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]