Kusatsu/Shiga, Japan – January 29, 2021 -  Takara Bio Inc. announced that it has acquired ISO 13485 certification, an international standard for quality management system for in vitro diagnostics, at its Head Office (Kusatsu, Shiga). The office has acquired the approval for manufacturing and marketing of in vitro diagnostics and certification for the manufacturing. With this certification, it plans to begin full-scale manufacturing in vitro diagnostics such as PCR testing reagents.


  Takara Bio Group will focus on quality management and provide high-quality and superior products and services with in vitro diagnostics and research reagents in the life science field.




JIS Q 13485:2018 (ISO 13485:2016)

Organization registered

Takara Bio Inc.

Business unit

Bioindustry and Regenerative Medical Products Manufacturing

Head office


7-4-38 Nojihigashi, Kusatsu, Shiga

Scope registered

  1. Design, Development, Production and Sales of Raw Materials for In Vitro Diagnostics
  2. Design, development, , Production and Sales of In Vitro Diagnostics

Date of registration

January 8, 2021

Accreditation no.


This is an English translation from Japanese press release.