Order # 22602400 Manufacturer# 20260 Brand Sofia RSV FIA Manufacturer Quidel Application Rapid Diagnostic Test Kit CLIA Classification CLIA Waived For Use With For Sofia Fluorescent Immunoassay Analyzer Kit Contents Individually Packaged Cassettes (25), Reagent Tubes (25), Reagent Solution (25), Nasopharyngeal Swabs (25), Large Pipettes (25), Small Pipettes (25), Positive Control Swab (1), Negative Control Swab (1), Printer Paper (1), Package Insert Number of Tests 25 Tests Reading Type Machine Read Sample Type Nasopharyngeal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample Storage Requirements USP Controlled Room Temperature Test Format Cassette Test Name Respiratory Syncytial Virus Test (RSV) Time to Results 15 Minute Results Type Fluorescence Immunoassay (FIA) UNSPSC Code 41116144 The Sofia RSV Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect respiratory syncytial virus (RSV) nucleoprotein antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens All components included in the kit Compatible with Influenza A&B Extraction Reagent means when testing with Sofia RSV FIA, a single patient sample may also be used to test with Sofia Influenza A&B FIA Fixed volume pipette collects and dispenses correct amount of sample needed for testing Room temperature storage CLIA Waived for children less than 7 years of age CLIA Moderate Complexity for pediatric patients 7 to less than 19 years of age