SEKISUI DIAGNOSTICS, LLC

SEKISUI DIAGNOSTICS LLC specializes in the manufacturing of in-vitro diagnostic substances, with a demonstrated focus on rapid diagnostic tests and laboratory reagents for public health applications. The company’s technical expertise lies in the development and production of clinical assay platforms, including over-the-counter infectious disease tests such as COVID-19 antigen detection systems, and the supply of calibrated laboratory products supporting clinical and research workflows. Their capability extends to regulatory-compliant manufacturing processes aligned with FDA guidelines for diagnostic reagents, ensuring batch consistency, stability, and traceability across sensitive healthcare environments. A key differentiator is their ability to deliver scalable, high-volume diagnostic solutions tailored for federal health programs requiring rapid deployment and reliable performance under real-world conditions. The contractor has established a consistent relationship with the Department of Health and Human Services, supplying critical diagnostic materials for public health surveillance and emergency response initiatives, and has also supported the Department of Veterans Affairs with laboratory-grade diagnostic products for clinical use in VA medical facilities. Their engagement with the NAC Federal Supply Schedule indicates integration into broader federal procurement channels, enabling streamlined access for multiple government entities. The primary NAICS code 325413 reflects a dedicated focus on in-vitro diagnostic substance manufacturing, positioning the company within the clinical diagnostics supply chain, particularly in point-of-care and centralized lab testing markets. Their specialization is narrowly focused on reagent-based diagnostics rather than instrumentation, distinguishing them from broader medical device manufacturers. SEKISUI DIAGNOSTICS LLC operates as a 2L entity headquartered in Burlington, Massachusetts, with no active government certifications on record. Their geographic presence is centralized in the U.S. biotech corridor, supporting federal health agencies through direct manufacturing and supply chain reliability rather than through third-party distribution networks.