Sekisui OSOM Flu SARS-CoV-2 Combo Test Kit

Description

OSOM Flu SARS-CoV-2 Combo Test is a lateral flow in vitro diagnostic for rapid and simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens for Healthcare providers. For Emergency Use Authorization Only.

• One Sample, One Test, and Three Steps to reliably differentiate between SARS-CoV-2, Flu A, and Flu B.
• Improve clinical outcomes by quickly differentiating between SARS-CoV-2, Flu A, and Flu B in 10 minutes with one sample collection.
• The signature OSOM™ QC Inside™ feature gives you two additional tests in each box so that external quality controls can be performed without impacting your bottom line.
• The OSOM™ Flu SARS-CoV-2 Combo Test Kit is EUA approved for anterior nasal swab samples in the CLIA waived, moderate, and high complexity laboratory settings.

Specifications

• CE Marker: No
• Clia Complexity: Waived (EUA)
• Detectable Analytes: SARS-CoV-2, Influenza A and B
• Detection Method: Manual Antigen
• DoA Calibrators: No
• Format: Kit
• Sample Type: Anterior Nasal Swab
• Sensitivity: High
• Type: lateral flow immunochromatographic
• For Use With (Application): Detection and Differentiaion of influenza A, influenza B, and SARS-CoV-2
• Form: Ready-to-Use (RTU)

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.