Package Inserts and Product Documentation

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

Find Documents by...

Product Category

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

Product Name

Language

- Any -EN - EnglishBP - Brazilian PortugueseCF - Canadian-FrenchCS - CzechDA - DanishDE - GermanEE - EstonianEL - GreekES - SpanishFI - FinnishFR - FrenchHR - CroatianHU - HungarianIT - ItalianJA - JapaneseKO - KoreanLE - LatinAm SpanishLT - LithuanianLV - LatvianNO - NorwegianNL - DutchPL - PolishPT - PortugueseRO - RomanianRU - RussianSR - SerbianSV - SwedishTH - ThaiTR - TurkishTW - Taiwanese/Chinese, TraditionalVI - VietnameseZH - Chinese, SimplifiedMultiple

Document Category

- Any -Instructions for Use (IFUs)Marketing CollateralTech SupportCompliance

Document Title

Document Type

- 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

Search Results

Product Category: Sofia

Product

Documents

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  EN -EU SDS Multiple  DE, IT, FR, ES, PT SDS EN - English  SDS Sales Sheet EN - English  EN - Canada Sales Sheet EN - English  EN - XUS Sales Sheet DE - German  DE - XUS Sales Sheet IT - Italian  IT -XUS Sales Sheet EN - English  Sales Sheet CLSI EN - English  CLSI Package Insert Multiple  DA, NO, SV Package Insert EN - English  EN - Canada Package Insert CF - Canadian-French  CF - Canada Package Insert Multiple  Controls -BP, DE, IT, FR, ES, PT Package Insert Multiple  Controls -DA, NL, NO, SV Package Insert EN - English  US - EUA Package Insert EN - English  Control Swab Set -EN Package Insert EN - English  EN - CE Package Insert Multiple  DE, IT, FR, ES Package Insert Multiple  BP, NL, PT 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 Training Tools EN - English  Proper Pipetting Technique Quiz EN - English  For use with Sofia and Sofia 2 Quiz EN - English  For use with Sofia Q FAQ EN - English  FAQ Quick Reference Instructions EN - English  Batch Testing Protocol Quick Reference Instructions EN - English  English -XUS 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  Quick Reference Instructions Sample Collection EN - English  How To Obtain Nasal/Nasopharyngeal Swab Specimens Fact Sheet EN - English  Healthcare Providers Fact Sheet EN - English  Patients Fact Sheet CF - Canadian-French  Healthcare Providers - CF Fact Sheet ES - Spanish  Healthcare Providers - ES Fact Sheet CF - Canadian-French  Patients - CF Fact Sheet ES - Spanish  Patients - ES