Respiratory Test Kit OSOM® Flu A + B / SARS-CoV-2 Combo 25 Tests
 
Manufacturer #
1080
Brand
OSOM®
Manufacturer
Sekisui Diagnostics
Country of Origin
United States
Application
Respiratory Test Kit
Contents 1
Each Kit contains: (25) Sterile Nasal Swabs, (27) Test Sticks, (1) Flu A / Flu B / SARS-CoV-2 Positive Control Swab, (1) Flu A / Flu B / SARS-CoV-2 Negative Control Swab, (2) Result Interpretation Cards, IFU, Quick Reference Guide, (1) Workstation
HCPCS
K1034
Is_ECAT
N
Is_GSA
Y
Is_VA
N
Number of Tests
25 Tests
Product Dating
McKesson Acceptable Dating: we will ship >= 90 days
Purchase Program Type
Standard Purchase
Reading Type
Visual Read
Sample Type
Anterior Nasal Swab Sample
Specialty
Immunoassay
Test Format
Test Device Format
Test Kit Type
Rapid
Test Method
Lateral Flow
Test Name
Flu A + B / SARS-CoV-2 Combo
Test Type
Antigen Test
Time to Results
10 Minute Results
UNSPSC Code
41116144
Features
The OSOM® Flu SARS-CoV-2 Combo Test is under FDA Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Results are for the simultaneous in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigen, but does not differentiate, between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens
Positive results do not rule out bacterial infection or co-infection with other viruses; the agent detected may not be the definitive cause of disease
All negative results are presumptive, and should be confirmed with a molecular assay, if necessary, for patient management
Negative results do not rule out influenza or SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks
Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with each respiratory infection
Rapid: Differentiate between three viral infections (COVID-19, Flu A, & Flu B) in only 10 minutes at the point-of-care
 
MFR# 1080
SKU: 314-0025
SKU2: 1253219