OSOM Flu SARS-CoV-2 Combo Test

• Rapid Detection & Differentiation Between SARS-CoV-2, Influenza A or B
• Fast & Accurate Results Within 10 Minutes
• Uses Anterior Nasal Sample
• Authorized by the FDA Under an EUA, Pending FDA Clearance
• CLIA-waived & Approved for Point-Of-Care Testing
• Shelf Life: 20 Months .

The Sekisui OSOM Flu SARS-CoV-2 Combo Test quickly and accurately detects and differentiates between COVID-19, Flu A, and Flu B in point-of-care settings. This enables better-informed decisions for treating patients with symptoms of viral infections.

RELIABLE & FAST TRIPLE-VIRUS DETECTION

BROAD & PROVEN DETECTION: Accurately identifies SARS-CoV-2, Influenza A & B, and even multiple avian flu strains (H5N1), supported by strong clinical performance to reduce misdiagnosis.

FDA EUA AUTHORIZED: Approved under Emergency Use Authorization for SARS-CoV-2 antigen detection in point-of-care settings.

FAST DIFFERENTIATION: Delivers accurate results for COVID-19, Flu A, and Flu B in just 10 minutes for immediate treatment decisions.

COST-EFFICIENT & READY-TO-USE: Includes extra QC tests under the QC Inside feature and arrives with prefilled extraction buffers for simple, CLIA-waived operation.

With quick, accurate detection and differentiation of COVID and the flu, the Sekisui OSOM Flu SARS-CoV-2 Combo Test can help keep families safe while slowing the spread of the virus in the broader community.

FDA DISCLAIMER:

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

WARNING: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.