Respiratory Test Kit BinaxNOW® Respiratory Syncytial Virus Test (RSV) 10 Tests CLIA Waived

SKU # 533820 Manufacturer # 430100 Brand BinaxNOW® Manufacturer Abbott Rapid Dx North America LLC Country of Origin United States Application Respiratory Test Kit CLIA Classification CLIA Waived CLIA Classified CLIA Waived Contents 1 (10) Test Cards, Transfer Pipettes, Positive Control Swab (Inactivated RSV), Negative Control Swab, Elution Solution and NP Patient Swabs (with CLIA Waived Kits), Product Insert, Procedural Card Is_Active_Vendor Y Is_DSCSA N Is_Discontinued N Is_Medical_Device N Lot_Tracking_Flag Y Number of Tests 10 Tests On_Allocation N Product Dating McKesson Acceptable Dating: we will ship >= 90 days Purchase Program Type Standard Purchase Reading Type Visual Read Sample Type Nasopharyngeal Swab / Nasal Wash Sample Specialty Immunoassay Supplier_ID 64711003 Test Format Test Card Format Test Kit Type Rapid Test Method Lateral Flow Method Test Name Respiratory Syncytial Virus Test (RSV) Test Type Infectious Disease Immunoassay Time to Results 15 Minute Results UNSPSC Code 41116144 Features BinaxNOW® RSV Card is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients Shelf Life: 24 months from the date of manufacture Retrospective nasal wash Sensitivity: 89% Specificity: 100% Prospective NP swab Sensitivity: 93% Specificity 93% This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in neonatal and pediatric patients under the age of 5