OSOM COVID-19 Antigen Rapid Test - 40/Kt

• Rapid detection of SARS-CoV-2
• Fast results in 15 minutes
• Uses direct Mid-Turbinate nasal swab
• Authorized by the FDA under an EUA, pending FDA clearance / approval
• CLIA waived
• Shelf life: 24 months from date of manufacture .

The Sekisui OSOM COVID-19 Antigen Rapid Test is designed for easy and accurate detection of COVID-19 in just 15 minutes in CLIA-waived point-of-care settings.

Convenient

• Direct Mid-Turbinate nasal swab collection involves minimum discomfort 
• Comes with every tool needed to run a test – no specialized equipment necessary
• Does not need refrigeration; store at room temperature 

Reliable Results

• Positive Percentage Agreement: 95.1%
• Negative Percentage Agreement: 97.0%

With quick and accurate detection of SARS-CoV-2, the Sekisui OSOM COVID-19 Antigen Rapid Test can aid prompt patient treatment and potentially stop 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.