SEKISUI Diagnostics Launches 510(k)-Cleared COVID-19 and Flu A&B Combo Test

29 October 2026 | Thursday | News

The CLIA-waived rapid test differentiates SARS-CoV-2 and influenza A and B from a single nasal swab, supporting point-of-care respiratory infection testing.

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has announced the launch of a 510(k) cleared rapid test to detect COVID-19 and Flu A&B in professional healthcare settings.

The OSOM COVID-19/Flu A&B Combo Test includes QC Inside®, a unique feature which maximizes the value of every kit by eliminating separate Quality Control (QC) costs and provides two additional patient tests for external QC at no charge. 

"With the Emergency Use Authorization ending, we know it is extremely important to continue to supply the market with the tools needed to diagnose respiratory infections quickly and accurately. We are pleased to be able to offer new customers and transition existing customers to a 510(k) cleared alternative as we enter the season, so they are well prepared before the termination takes effect." said Erica Blight, VP Strategy & Growth.

As COVID-19 and influenza continue to present with overlapping symptoms, multiplex testing provides the advantage of identifying and differentiating multiple respiratory viruses from a single patient sample, helping support timely clinical decisions.

SEKISUI Diagnostics is a well-known provider of many rapid diagnostic solutions to the professional and home testing markets through a portfolio of tests under the OSOM and Metrix® brands.

 

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