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 / approval
• CLIA-waived & approved for point-of-care testing
• 25 tests per kit .

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.

Results You Can Trust

• Proven clinical performance to help reduce misdiagnosis and inappropriate treatment
• Emergency Use Authorized by the FDA for detection of SARS-CoV-2 antigen

Convenient

• Eliminates the need for rehydration or dispensing with ready-to-use extraction buffers

• Quality control made easy with the unique QC Inside feature that provides two additional tests for external quality control testing

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

FDA Disclaimers:

• 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.