{"product_name":"FluChip-8G Influenza A+B Assay","company_name":"InDevR","product_url":"https://www.indevr.com/flu-chip-8g-influenza-ab-assay","company_url":"https://www.indevr.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0559","summary":"FluChip-8G Influenza A+B Assay is a diagnostic tool developed by InDevR for the rapid detection and differentiation of seasonal and non-seasonal influenza A viruses, as well as the genetic lineage of influenza B viruses, providing same-day results.","description":"FluChip-8G is an in vitro diagnostic assay that utilizes multiplexed RT-PCR amplification of whole influenza gene segments, combined with microarray detection and AI-based pattern recognition, to identify and characterize influenza A and B viruses, including subtypes with pandemic potential like H7N9 and H5N1.","categories":["diagnostic Support","clinical Care","infectious Diseases","laboratory Testing","Diagnostic","Clinical","Infectious Disease","Laboratory Testing"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","laboratory technicians","public health officials"],"specialties":["Infectious Disease","Virology","Epidemiology"],"regions_available":["United States","Canada","European Union","Australia","Japan","South Korea","China","India","Brazil","Mexico","South Africa","Russia","South East Asia","Middle East","Africa","Latin America","Caribbean","New Zealand","Pacific Islands","Central America"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"contact vendor","pricing_details":"Pricing details are not publicly disclosed; please contact InDevR for more information.","license":"commercial","company_offices":["United States","Canada","European Union","Australia","Japan","South Korea","China","India","Brazil","Mexico","South Africa","Russia","South East Asia","Middle East","Africa","Latin America","Caribbean","New Zealand","Pacific Islands","Central America"],"company_founding":"2003","deployment_model":["on_prem"],"os_platforms":["Windows","macOS","Linux"],"features":["Qualitative detection and differentiation of seasonal and non-seasonal influenza A viruses","Identification of influenza B virus genetic lineages","Same-day results","Multiplexed RT-PCR amplification of whole influenza gene segments","Microarray detection","AI-based pattern recognition for automated interpretation"],"optional_modules":[],"integrations":["Laboratory Information Management Systems (LIMS)"],"data_standards":["HL7 v2","DICOM"],"api_available":"unknown","system_requirements":"Windows 7 or later, macOS 10.12 or later, Linux kernel 3.10 or later","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["Data encryption","Access control","Audit logs"],"privacy_features":["Data anonymization","Data minimization"],"data_residency":"US-based data centers","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0559","slug":"fluchip-8g-influenza-a-b-assay","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/fluchip-8g-influenza-a-b-assay.json"}}