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Your In Vitro Diagnostics Manufacturing Partner

As a manufacturer of in vitro diagnostic products, you want quality materials and systems that best meet the needs of your customers. You need a reliable contract development and manufacturing partner who will help you control fixed costs – and provide you with the speed, sensitivity and accurate outcomes your customers demand. You also need a partner who offers a broad product portfolio that sets industry standards for reliability and performance.

Diagnostic and Contract Manufacturing Experience

With more than 1.7 billion clinical chemistry tests performed each year under a wide range of market-leading brands, SEKISUI Diagnostics supplies both off-the-shelf and customized diagnostics tests, reagents, instrument systems, enzymes and raw materials to global and regional partners.

A leading and trusted supplier to the IVD industry, we believe in providing our customers with choices. When working with SEKISUI Diagnostics, you can either purchase ready-made assays and reagents or simply acquire the raw materials needed to manufacture your product.

Co-Development and Custom Development Project Expertise

When you need the next new product to keep you ahead of your competition, you can turn to SEKISUI Diagnostics for custom contract development. We offer a full spectrum of flexible contract development and contract manufacturing services to meet your technical specifications and/or custom labeling – including formulation, OEM manufacturing, enzymes and raw materials, fill & finish and more.

By partnering with us, you’ll have access to our:

  • Manufacturing and development expertise. Development, co-development and production of new products and technologies targeted to the needs of your customers.
  • Global technical service and customer support. Responsive service and support through our technical centers of excellence with skilled product specialists available to take your call.
  • Dedicated business-to-business sales team. Our experienced team learns about your requirements and assists you in building solutions.

Learn more about our enzyme contract manufacturing services

Global Manufacturing Facilities

We work with a diverse range of manufacturers – from small companies to top global brands – supplying them with systems, enzymes, assays and reagents. SEKISUI Diagnostics’ contract manufacturing facilities meet stringent regulatory standards. With manufacturing and distribution operations in North America, Europe and Asia, we help you bring products to customers worldwide.

Our expertise in international shipping, import/export requirements, REACH regulations and Global Harmonization Standards means that you can count on your materials and products being delivered on time.

Built-in Quality

Robust quality systems and ISO certifications ensure that the products we produce for you will meet or exceed your customers’ expectations.

Quality is the foundation of our business. Every point in the production process is critical to ensuring that your product is delivered with the exact specifications you require. Our ISO13485, 9001, 14001, CMDCAS, FDA Facility Registration and OHSAS 1801 certifications guarantee that your finished product will always meet high quality standards and responsible manufacturing requirements.

Quality management systems and precise manufacturing ensure lot-to-lot consistency. Accurate release analysis helps you formulate your final product – without the need to perform incoming testing. All of the products we manufacture are tested by highly-trained Quality Control analysts before being released to you by our Quality Assurance Department.

We have company-wide Continuous Improvement programs such as Lean Six Sigma which relies on a collaborative team effort to improve performance by systematically removing waste and reducing variation. This leads to improved quality of our products and a more efficient and safe manufacturing environment.

Lab managers and med techs value SEKISUI Diagnostics products – from the higher-than-normal sensitivity of our Ultra Strep A Test* and our trailblazing leadership in HDL/LDL testing to the breadth of our infectious disease expertise and the market-leading position of our Mono rapid diagnostic test in the U.S.

Our product lines include:

Learn more about how we work with you to bring your in vitro diagnostic product to market.

Contact us to learn more about contract manufacturing for the clinical chemistry, point of care testing and coagulation markets.

 *Refer to package insert for details