Overview

SEKISUI Diagnostics makes diagnostic tests, reagents, and systems, including clinical chemistry reagents, coagulation systems, and point-of-care rapid tests. The company is headquartered in Burlington, Massachusetts, was founded in 2011, and employs an estimated 200 to 500 people. It is privately held and part of the SEKISUI Medical Group, serving the medical, automotive, electronics, and industrial equipment sectors. In October 2026 it announced 510(k) clearance and launch of the OSOM COVID-19/Flu A&B Combo Test.

At a glance

What Sekisui Diagnostics makes

The company holds ISO 9001 certification and lists products that include clinical chemistry reagents, coagulation systems, and point-of-care rapid tests.

Products and capabilities described on the company's own site include Plastic (source: sekisuidiagnostics.com).

Certifications

Sekisui Diagnostics is associated with the following certifications in public sources. Confirm the certified scope for the specific plant producing your part:

• ISO 9001 — sekisuidiagnostics.com

Latest developments

• 2026-10-22 — SEKISUI Diagnostics Announces 510(k) Clearance and Launch of the OSOM® COVID-19/Flu A&B Combo Test - Sekisui Diagnostics (sekisuidiagnostics.com)

• 2026-03-05 — Powering Biotech Innovation in the UK: SEKISUI’s Custom Fermentation Solution to Drive Biologics Manufacturing Forward - BPES (bioprocess-eng.co.uk)

• 2026-02-13 — Why SEKISUI invested in Charlottetown for its largest manufacturing facility in North America - Sekisui Diagnostics (sekisuidiagnostics.com)

• 2025-11-12 — Microbix Partners with SEKISUI Diagnostics to Support COVID/Flu Tests - Microbix (microbix.com)

• 2025-11-11 — [Precision Biosensor’s U.S. subsidiary Nano Ditech Corp signs 10-year exclusive supply agreement with SEKISUI Diagnostics ] | Precision Biosensor (linkedin.com)

• 2025-06-18 — SEKISUI Diagnostics’ Post (linkedin.com)

Facilities

Sekisui Diagnostics is headquartered in Burlington, Massachusetts. Public sources also reference these locations:

• Canada — sekisuidiagnostics.com

Company details

SEKISUI Diagnostics is part of the SEKISUI Medical Group and, per an estimated revenue band of $100 to 250 million, operates at a mid-sized scale. Sekisui Diagnostics was founded in 2011, has an estimated 200-500 employees, and is headquartered in Burlington, Massachusetts. On the LightSource stability read it is rated "Established & active": 15 years in operation (founded 2011). Holds ISO 9001 certification(s) per public sources.

Frequently asked questions

What does Sekisui Diagnostics do?

SEKISUI Diagnostics makes diagnostic tests, reagents, and systems, including clinical chemistry reagents, coagulation systems, and point-of-care rapid tests. The company is headquartered in Burlington, Massachusetts, was founded in 2011, and employs an estimated 200 to 500 people. It is privately held and part of the SEKISUI Medical Group, serving the medical, automotive, electronics, and industrial equipment sectors. In October 2026 it announced 510(k) clearance and launch of the OSOM COVID-19/Flu A&B Combo Test.

Where is Sekisui Diagnostics headquartered?

Sekisui Diagnostics is headquartered in Burlington, Massachusetts (1 Wall Street, Burlington, Massachusetts, 01803).

When was Sekisui Diagnostics founded?

Sekisui Diagnostics was founded in 2011.

How big is Sekisui Diagnostics?

Sekisui Diagnostics has an estimated 200-500 employees, with revenue in the $100-250M range (estimated).

What certifications does Sekisui Diagnostics hold?

Sekisui Diagnostics lists ISO 9001 on its website. Confirm the certified scope for the specific plant producing your part.

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Last verified Nov 2026. Is this your company? Request a correction.