Package Inserts and Product Documentation

By default Package Inserts and Instructions for Use (IFU) documents are displayed. View the Document Category Legend for details.

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- Any -Molecular Diagnostics-Lyra-Solana-SerosepImmunoassays-MicroVue-QuickVue-Sofia-Virena-InflammaDryDHI Cell Culture and Fluorescent Tests-D³-ELVIS-FreshCells-ReadyCells-Thyretain-CopanResearch-MicroVue-TECOmedical

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- Any -BrochureClinical StudiesComplianceEC Declaration of ConformityFact SheetInstallation InstructionsPhysician ResourcesQuality Control RecordReimbursementCLSIFAQInstructions for UseInstruction ManualPackage InsertPackage Insert – Moderately ComplexPackage Insert (USA and CE-IVD Versions)Package Insert – WaivedPress ImagesProcedure CardQuick Reference CardQuick Reference InstructionsQuickStart GuideQuizSales SheetSample CollectionSDSTechnical BulletinTechnical Data SheetTraining ToolsUser ManualWhite Papers

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Product Category: Sofia

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Sofia SARS Antigen FIA

Type Language Title Link|Patient and Provider FAQ Sheet|https://data.cms.gov/download/tv7a-xetf/application%2Fpdf SDS EN - English  SDS SDS EN - English  EN -EU SDS Multiple  DE, IT, FR, ES, PT Sales Sheet EN - English  Sales Sheet Sales Sheet EN - English  EN - Canada Sales Sheet EN - English  EN - XUS Sales Sheet DE - German  DE - XUS Sales Sheet IT - Italian  IT -XUS CLSI EN - English  CLSI Package Insert EN - English  English – Australia only Package Insert EN - English  CE - English Package Insert DE - German  CE - German Package Insert ES - Spanish  CE - Spanish Package Insert FR - French  CE - French Package Insert IT - Italian  CE - Italian Package Insert PT - Portuguese  CE - Portuguese Package Insert NL - Dutch  CE - Dutch Package Insert DA - Danish  CE - Danish Package Insert NO - Norwegian  CE - Norwegian Package Insert SV - Swedish  CE - Swedish Package Insert EN - English  EN - Canada Package Insert CF - Canadian-French  CF - Canada Package Insert EN - English  US - EUA Package Insert Multiple  Controls -BP, DE, IT, FR, ES, PT Package Insert EN - English  Control Swab Set -EN Package Insert Multiple  Controls -DA, NL, NO, SV Technical Bulletin EN - English  Liquid Proficiency Sample Testing Procedure Technical Bulletin EN - English  Antigen CPT Code Technical Bulletin EN - English  Antigen vs. Antibody Testing Technical Bulletin EN - English  Detection of SARS-CoV-2 and SARS-CoV Technical Bulletin EN - English  SARS-CoV-2 Virus Inactivation Technical Bulletin Multiple  SARS-CoV-2 Virus Inactivation - CF, DE, ES, FR, IT Technical Bulletin EN - English  Firmware 1.12 Update Training Tools EN - English  Proper Pipetting Technique Quiz EN - English  For use with Sofia and Sofia 2 FAQ EN - English  FAQ Quick Reference Instructions Multiple  BP, EL, ES Quick Reference Instructions Multiple  DE, IT, FR Quick Reference Instructions CF - Canadian-French  CF Quick Reference Instructions EN - English  Batch Testing Protocol Quick Reference Instructions EN - English  Quick Reference Instructions Quick Reference Instructions EN - English  English -XUS Sample Collection EN - English  How To Obtain Nasal/Nasopharyngeal Swab Specimens Fact Sheet EN - English  Healthcare Providers Fact Sheet EN - English  Patients Fact Sheet FR - French  Healthcare Providers - FR Fact Sheet ES - Spanish  Healthcare Providers - ES Fact Sheet FR - French  Patients - FR Fact Sheet ES - Spanish  Patients - ES