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History

Founded in 1999, Tyson Bioresearch Inc. is an innovative medical diagnostic manufacturing company dedicated to providing products and services to accelerate the development and commercialization of diagnostics. The Company supplies its products and services worldwide to research organizations, biomedical and medical device distribution companies.


 

History

Year

Events

01/2009

EZ Take Lancing Device receives Class I Ministry of Health issued Medical Device Certificate (No.000620)
Received Taiwan Patent announcement on Integrated Blood Medical Diagnostic Device

08/2008

TysonBio Link Health Management System (EZ Smart, Diachex, and Diachex+ model series) receive FDA approval (510K# K081726)

07/2008

Perfect Mini Blood Glucose Monitoring System receives FDA approval (510K# K052818A006)

06/2008





Receive approval of initial public offering form Securities and Futures Bureau
EZ Plus Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002586)
Diachex Basic, Diachex Superb, and Diachex Vigor Glucose Monitoring System receive FDA approval (510K# K072854)

04/2008






Received Taiwan Patent (M334703) on " Integrated Blood Medical DiagnosticDevice
T514, T513, T512 Glucose Monitoring System receives People's Republic of China SDA approval (No.2008_2400022)
Smartchex Control Glucose Monitoring System receives People's Republic of China SDA approval (No.2008_2400026)
Diachex+ Determine and Diachex+ Infinity Blood Glucose Monitoring System receives FDA approval (510K# K073492)

03/2008



Clarity Blood Glucose Monitoring System receives FDA approval (510K# K062829/A003)
EZ Scan Plus Blood Glucose Monitoring System receives FDA approval (510K# K072441)

02/2008




Obtained People's Republic of China patent on "Multi-functions Portable Diagnostic Device & Display Method" (No.381064)
T502 Glucose Monitoring System receives People's Republic of China SDA approval (No.2008_2400010)

11/2007


Merge and acquire Mihorng Technology Ltd

10/2007


Ultimate EZ Smart Plus Blood Glucose Monitoring System receives FDA approval (510K# K052818/A005)

08/2007



Diachex Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002460)
Smartchex Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002461)

06/2007




EZtake Lancing Device receives Ministry of Health issued Medical Device Certificate (No.001901)
EZ Smart 608 Blood Glucose Monitoring System receives FDA approval (510K# K062829A002)

04/2007


Received Taiwan Patent (I 279222) on "Multi-functions Portable Diagnostic Device & Display Method

03/2007


Smartchex Blood Glucose Monitoring System receives FDA approval (510K# K052818A004)

01/2007

EZ Scan Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002309)

12/2006




HIV One Step Rapid Test & Glucose Monitoring System received Quality Product Silver Medal from Taiwan Biotechnology & Medical Committee.
Taiwan National Health Research Institute & regional Health Department receives a donation of 10,000 HIV One Step Rapid Tests for nation-wide HIV screening campaign

11/2006

Received Taiwan Patent (I 274876) on "Multi-detection Biosensor Strip

10/2006

Diachex Blood Glucose Monitoring System receives FDA approval (510K# K062829)

09/2006

EZ Smart 608 Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002178)

08/2006



HIV One Step Rapid Test & Glucose Monitoring System received Quality Product SNQ Certification from Taiwan Biotechnology & Medical Committee.
EZ Smart 606 Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002170)

06/2006



EZ Smart 168 Blood Glucose Monitoring System receives Ministry of Health issued Medical Device Certificate (No.002161)
EZ Smart 168 Blood Glucose Monitoring System receives FDA approval (510K# K052818)

04/2006

Joint research and development with National Taiwan University on novel diagnostic method for Tuberculosis.

03/2006






Disposal lancet receives Ministry of Health issued Medical Device Certificate (No.000144)
In compliance to new medical guidance, Hepatitis C (HCV) receives Ministry of Health newly issued Medical Device Certificate (No.002003); old Certificate (No.000118 void)
In compliance to new medical guidance, HIV receives Ministry of Health newly issued Medical Device Certificate (No.002013); old Certificate (No.000119 void)

01/2006


Sponsor and support Taiwan AIDS Foundation and Taiwan Homesexual Foundation on HIV screening event

12/2005




EZ Smart Glucometer receives Ministry of Health issued Medical Device Certificate (No.001954)
Obtained People's Republic of China patent on "Revisable Biosensor" (No.239238)
Obtained People's Republic of China patent on "Biosensor Test Strip Structure" (No.ZL200420116622.2)

11/2005



EZ Smart control solution receives Ministry of Health issued Medical Device Certificate (No.000771)
EZ Smart test strip receives Ministry of Health issued Medical Device Certificate (No.001929)

06/2005



GMP auditing approval on EZ Smart lactometer
HIV One Step Rapid Test requested by Kaohsiung City Government Tender
Received Taiwan Patent (M268579) on "Biosensor Test Strip"

03/2005



GMP auditing approval on HIV, HCV One Step Rapid Test, EZ Smart Test Strip and control solution
EZ Smart Glucose product winning Turkey tender

01/2005

Tyson Bioresearch, Inc. USA office incorporated

10/2004



Received Innovative Product Recommendation Certificate from Ministry of Economics
HIV One Step Rapid Test receives People's Republic of China SDA approval (No.CS20040001)

09/2003



Awarded (1) Outstanding Company, (2) Outstanding Leadership, and (3) Outstanding Product award by Taiwan Management Association.
Selected by Ministry of Health in supporting Iraq Medical Initiative Program

07/2003



Received grant from Ministry of Economics on development of SARS One Step Rapid Test in amount of $300,000
Received validation approval by WHO appointed laboratory on HIV One Step Rapid Test

05/2003


Relocated Headquarters and manufacturing facility to HsinChu Science Based Industrial Park, ChuNan, Taiwan

04/2003


Obtained Certificate of Free Sales (domestic & international) from Ministry of Health on EZ Smart Glucose product

10/2002


Obtained CE Certification (TU01073-161)

09/2002


Obtained Manufacturing License from Ministry of Health on HIV One Step Rapid Test (No.000119)

08/2002


Obtained Manufacturing License from Ministry of Health on HIV One Step Rapid Test (No.000118)

01/2002


Received grant on development of Tuberculosis One Step Rapid Test in amount of $300,000

12/2001




Received Ministry of Health issued HIV One Step Rapid Test Exportation License (No.000112)
Received Ministry of Health issued HIV One Step Rapid Test Exportation License (No.000114)

08/2001


Obtained Company and Product trademark and Copyright

05/2001


Receive cGMP approval

02/2001


HIV One Step Rapid Test receives Brazil independent laboratory validation

12/2000


Received ISO 9001, EN 46001, and ISO 13485 certification and approval
Raised capital to $ 9.0 millions

10/2000



Completes HIV One Step Rapid Test technology transfer
Received validation approval by WHO appointed laboratory on HIV One Step Rapid Test

05/2000


Initiate pre-clinical study on glucose test strip
Raised capital to $ 6.5 millions

03/2000



Headquarters relocated to HsinChu Science Based Industrial Park, HsinChu, Taiwan
Raised capital to $ 4.5 millions

11/1999


Tyson Bioresearch, Inc. incorporated in Taipei
Taiwan with capital of $ 2.5 millions


 

   

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