Respiratory Test Kit Sofia RSV FIA Fluorescence Immunoassay (FIA) Respiratory Syncytial Virus Test (RSV) Nasopharyngeal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample 25 Tests CLIA Waived

Mfr# 20260

• 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

Application Respiratory Test Kit CLIA Classification CLIA Waived CLIA Classified CLIA Waived Contents 1 (25) Individually Packaged Cassettes, (25) Reagent Tubes, (25) Reagent Solution, (25) Nasopharyngeal Swabs, (25) Large Pipettes, (25) Small Pipettes, Positive Control Swab, Negative Control Swab, Printer Paper, Package Insert For Use With For Sofia® or Sofia 2® Fluorescent Immunoassay Analyzer Number of Tests 25 Tests Product Dating Acceptable Dating: we will ship >= 60 days Purchase Program Type Standard Purchase Reading Type Machine Read Sample Type Nasopharyngeal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample Specialty Immunoassay Test Format Cassette Format Test Name Respiratory Syncytial Virus Test (RSV) Test Type Fluorescence Immunoassay (FIA) Time to Results 3 to 15 Minute Results UNSPSC Code 41116144