Quality Control

Outline

Nigata Factory Denka Seiken Co., Ltd. is a publicly traded biomedical company founded in 1950 with its head office in Tokyo and manufacturing facilities in Niigata, Japan. The company has 341 employees and annual sales of 9.4 billion yen (est. US $78 million). We develop, manufacture and distributes high quality in vitro diagnostic reagents and vaccines. Top export products include direct and automatable HDL and LDL reagents, latex-enhanced serum protein tests for hsCRP, rheumatoid factor, myglobin, ferritin and others. Rapid diagnostic test kits for MRSA, E. coli O157, parvo B19, Norwalk-like and influenza viruses are also market leaders in many countries around the world. Denka Seiken possesses numerous collaborative business relations with world-wide top ten diagnostic companies, and has ISO 9001 and 14001 certification as well as a number of products FDA-cleared for sale in the US. More recently, the company has developed a wide range of products for food and environmental testing.
Denka Seiken has established its first international branch office in the UK to assist in the promotion of its extensive line of diagnostics reagents for clinical chemistry and infectious disease testing. Recently the US branch office was established, complementing the UK office for promotional marketing activities, setting up of clinical trials and new product evaluations, and proving FDA-related regulatory support to the head office.

Company Name Denka Seiken Co., Ltd.
Head Office 3-4-2 Nihonbashi-kayabacho, Chuo-ku, Tokyo 103-0025, Japan
Establishment February 11, 1950
Paid-in Capital 1,000 million YEN(JP)
Number of Employees
(As of April 1, 2006)
452
Business Production, sales and import and export of vaccines for human use, immunological, clinical chemical, bacteriological, and virological diagnostic reagents and food/environment testing reagents
Fiscal year ends March
Board of Directors and Corporate Auditors(As of June 21, 2008) President and Representative Director: Masatarou Satsuka
Managing Director: Junichi Sugiyama
Managing Director: Kenichi Takasugi
Managing Director: Michihiko Okudera
Managing Director: Kiyomiki Kawanami
Director: Akira Fujiwara
Director: Yoshitaka Kubota
Director: Tsunehiko Shimizui
Director: Higashi Ito
Director: Shinsuke Yoshitaka
Statutory Auditor: Kenichi Inoko
Auditor: Yukinori Tootake
Auditor: Teruzou Miyoshi
Senior Executive Officer: Mitsunori Yamada
Senior Executive Officer: Takemi Nakayoshi
Executive Officer: Chikai Sato
Executive Officer: Akira Obata
Offices Factories: Niigata Plant, Kagamida Plant (Gosen-shi, Niigata)
Sales Office: Tokyo, Osaka, Nagoya, Niigata, Fukuoka, Sapporo, Sendai
Subsidiaries Denka Seiken UK Limited
Denka Seiken USA Incorporated

History

1950 Feb. The forerunner of Denka Seiken was established by Toshiba Corporation
1952 Sep. Begins sales of bacteriological diagnostic reagents.
1966 May Begins sales of virological diagnostic reagents
1972 Oct. Begins sales of clinical chemstiry diagnostic reagents
1979 Jul. Ownership changes to Denka Kagaku Kogyo KK
1981 Jan. Begins sales of laboratory animal monitoring reagents
1982 Jan. Changes name to Denka Seiken Co., Ltd.
1986 Oct. Begins sales of immunochemistry serum protein diagnostic reagents
1992 Oct. Begins sales of environmental and food hygiene monitoring line of contact agar plates
1994 Jan. New Kamida facility built for clinical and immunochemistry reagent production
1997 Jun. Begins sales of direct, automatable HDL reagent
1998 May Obtains ISO 9001 certifcation
  Sep. Begins of sales of direct, automatable LDL reagent
1999 Dec. Offers its first IPO and is listed on JASDAQ
2000 June Obtains ISO 14001 certification
  Jul. Begins sales of or rapid slide latex latex agglutination MRSA-Screen
2001 Nov. Begins sales of rapid POCT influenza test kit Influ A/B Quick
2003 April Establishes Denka Seiken UK Limited
2003 July Obtains ISO 13485 certification
2004 April Establishes Denka Seiken USA Inc.
2005 July Obtains CMDCAS certification