Rapid Diagnostic Test Kit by Quidel Corporation

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	Fluorescent 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

25 Tests / Kit

Part Number(s):

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Rapid Diagnostic Test Kit 1