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Quality Assurance & Manufacturing Process

“We want to make people healthier through early detection and treatment of diseases”
With this in mind, Serotec Co., Ltd. was established in Sapporo in May 1981 as an independent specialized manufacturer of in vitro diagnostic reagents.

Quality Assurance

In vitro diagnostic reagents are intended for use in diagnosis of disease or other conditions. The results from in vitro diagnostic reagents can significantly influence patient diagnosis, management, treatment and overall clinical outcomes.Therefore, it is our mission to provide consistent, high-quality products and services.



Quality management system

Chitose factory uses quality management system (QMS) meeting the international ISO13485 standard to proactively prevent nonconforming products from occurring, and to comprehensively control production and manage quality.