SEKISUI Launches 510(k)-Cleared OSOM COVID-19/Flu A&B Combo Test
San Diego – October 29, 2026 -- SEKISUI Diagnostics has launched the OSOM COVID-19/Flu A&B Combo Test, a 510(k)-cleared rapid test that detects and differentiates SARS-CoV-2 and influenza A and B from a single anterior nasal swab in professional healthcare settings.
CLIA-waived assay is manufactured in the USA for point-of-care use
The product is a lateral flow immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. It is intended for individuals with signs and symptoms of respiratory tract infection. SEKISUI Diagnostics manufactures the test in the USA and backs it with a technical services team of medical laboratory professionals.
QC Inside feature removes separate quality control costs
Each kit includes QC Inside, which eliminates separate quality control (QC) costs. It also provides two additional patient tests for external QC at no charge.