Features
The OSOM Ultra Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection
It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections
Cleared for use with multiple viral transport media types
27 Tests (plus 2 extra for external QC)
OSOM Ultra Flu A&B Test was approved in November 2016 for CLIA Waiver status for Nasal and Nasopharyngeal Swabs meeting the FDA performance criteria
Manufacturer # 1006
Brand OSOMŽ Ultra
Manufacturer Sekisui Diagnostics
Country of Origin United States
Application Rapid Test Kit
CLIA Classification CLIA Waived for Nasal Swabs, Nasopharyngeal Swabs
Contents (25) OSOM Ultra Flu A & B Test Devices (2 Additional Tests for External QC), (25) Extraction Reagent in Capsules, (25) Sterile Swabs, Positive Control Swab, Negative Control Swab, Package Insert, Procedure Card
Number of Tests 25 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 14 days
Reading Type Visual Read
Sample Type Nasal Swab / Nasopharyngeal Swab / Nasopharyngeal Aspirate / Nasopharyngeal Wash Sample
Storage Requirements USP Controlled Room Temperature
Test Format Cassette Format
Test Name Influenza A + B
Test Type Infectious Disease Immunoassay
Time to Results 10 to 15 Minute Results
UNSPSC Code 41116144