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. We develop, manufacture and distribute high quality in vitro diagnostic reagents and vaccines. Top export products include direct and automatable HDL, LDL and sd-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, norovirus 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 focused on contract R&D and manufacturing for immunochemistry products.
Denka Seiken 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 Nihonbashi Mitsui Tower
1-1 Nihonbashi-Muromachi 2-chome,
Chuo-ku, Tokyo 103-8338, JAPAN
Establishment February 11, 1950
Paid-in Capital 1,000 million YEN(JP)
Number of Employees
(As of April 1, 2012)
578
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 April 1, 2012) President and Representative Director: Shigetoshi Toyooka
Senior Managing Director:Kiyomiki Kawanami
Managing Director: Akira Fujiwara
Managing Director: Yoshitaka Kubota
Managing Director: Chikai Sato
Director: Akira Obata
Director: Hiroshi Adachi
Director: Sakari Sekine
Director: Tetsuro Maeda
Director: Mitsukuni Ayabe
Statutory Auditor: Takashi Fukuda
Auditor: Tadashi Hashimoto
Auditor: Hideo Oishi
Auditor: Jiro Hiroe
Executive Officers: (As of April 1, 2012) Senior Executive Officer: Masaru Hirano
Senior Executive Officer: Kyouji Aoki
Senior Executive Officer: Tsukasa Muramatsu
Executive Officer: Yasuo Nakatomi
Offices Factories: Niigata Plant, Kagamida Plant(Gosen-shi, Niigata)
Branch Offices:Tokyo, Osaka
Sales Offices:Sapporo, Sendai, Nagoya, Fukuoka
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 Denki 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
2008 Mar. Delisting
2008 April The Company became a wholly owned subsidiary of, Denki Kagaku Kogyo KK