A World of Excellence in In-Vitro Diagnostic Kits & Reagents Home products FDA Approved Test Kits List

Current

1. Biotron Diagnostics Inc.

2. Biotron Diagnostics USA & Affiliates

Previous     

1. Sterling Biochemical Inc/Nuclear Diagnostics Inc.

Education

1.  University of Sheffield , England

2.  Heriot Watt University, Edinburgh Scotland,

3.  University of Windsor, Canada,

4.  University of Detroit, USA.

ABOUT US

Biotron Diagnostics Inc.(Biotron Diagnostics USA), formerly known as Nuclear Diagnostics Inc., and Sterling Biochemical Inc., has a history of over 32 years in successfully developing, designing, producing, selling and marketing a complete line of diagnostics reagents and kits for use in Hospitals, Medical Laboratories, Research Institutions and the Health Care and Pharmaceutical Industries. The strength of our company stems from a foundation of knowledge and experience in product development with a commitment to quality and cost effectiveness in the biotechnology field.

Early in the year 1980, Sterling Biochemicals Inc. of Dearborn, Michigan was acquired by Dr. G. Gagneja (Founder of Biotron Diagnostics Inc. California). Sterling Biochemical Inc. was engaged in the maufacturing of a complete line of Clinical Chemistry Kits and Reagents. About one year later Nuclear Diagnostics Inc. of Troy, Michigan was acquired by Dr. Gagneja. At the time, Nuclear Diagnostics Inc. was a manufacturer of Radio Immunoassay Kits and Reagents.


Biotron Diagnostics., products are developed, designed and produced with unique formulations using state-of the-art technology.  IVD Kits and Reagents are produced using the GMP Rules and Regulations of the United States Food and Drug Administration.

We are very proud of our high quality FDA approved product lines, particularly “Research Chemistries” & Immunochemistries, which are currently being sold to institutions such as: CDC, NIH, Prestigious Universities, Research Centers, Cancer Research Institutions, and other Government and Prestigious Private Hospitals. Biotron Diagnostics has been certified as a US Government Supply Administration Federal Vendor.  Products are competitively priced. Biotron Diagnostics’ main Mission is to produce and market USA Made and FDA approved IVD Kits and Reagents for USA and worldwide distribution .  OEM, Private Label, Bulk Reagents and , CRO and Technology Transfer Services are available.  Presently Biotron Diagnostics Inc. has three international branches (India, China and Latin America) and a worldwide distribution network.   Biotron Diagnostics has a reputation for high quality, performance and innovation. Biotron continues to provide high quality standard IVD Kits and Reagents while meeting the changing needs of the IVD industry. The company’s main objective is to continue to maintain high quality standards using the latest inventions, discoveries and technologies to develop its products. The strength of the company stems from knowledge and experience in high quality product development provided by Ph.D. Chemists, Biologists and Medical Doctors.


Dr. George Gagneja  

President /Chairman/ at Biotron Diagnostics Inc. & Biotron Diagnostics USA  & Affiliates

35 YEARS EXPERIENCE IN HEALTHCARE INDUSTRY: (IVD Kits and Reagents Production,Total Corporate Management &Total Technical Management)
CLINICAL LAB DIRECTOR /CLINICAL LAB CONSULTANT. Experience in Total Management of both Private and Hospital/Clinical Laboratories and improving poorly managed ones. Experience also includes expertise in implementation of CLIA 88 regulations including quality standards, CAP,CDC and COLA laboratory accreditation procedures
IVD MEDICAL DEVICE EXPERT/BIOMEDICAL INDUSTRIAL CONSULTANT. Excels in Project development& implementation .Experiences lie in GMP, ISO- 9000, FDA and NRC US regulatory compliances and CE Mark certification in biomedical industry. 
FOUNDER: BIOTRON DIAGNOSTICS USA & BIOTRON DIAGNOSTICS INTERNATIONAL 
Biotron Diagnostics Inc., formerly known as Nuclear Diagnostics Inc., and Sterling Biochemical Inc., has a history of over 35 years in producing, a complete line of IVD Kits for use in Hospitals, Medical Laboratories, Research Institutions and the Health Care and Pharmaceutical Industries.
DIRECTOR & CONSULTANT LABORATORY MEDICINE CONSULTANT. BULK PHARMACEUTICALS, INTERMEDIATES, CRO, Blood Plasma & Vaccines and Molecular Diagnostics. ( Turn Key Projects) 
AWARDS: 
BUSINESS ADVISORY COUNCIL HONORARY STATE CHAIRMAN. Recipient of the National Leadership Award & NRCC Business Advisory Council Honorary Chairman appointment. (President George Bush)


RECIPIENT OF 2002 REPUBLICAN GOLD MEDAL.
BUSINESSMAN OF YEAR AWARD. Recipient of the NRCC Businessman Award for Year 2003.


2004 RONALD REAGAN REPUBLICAN GOLD MEDAL AWARD WINNER.
IVD & Biotechnology Consultant Appointment by Chinese Local Government Wuxui Jingsu, China -Year 2011


Turn Key Operation in IVD & Healthcare Industry: Collaboration with Array Biotech, Nanjing (Chinese Gov.) , China Year-2013


IVD Platform for Expansion, Growth, Viability and Profitability, Year 2014
Chair Coach Invitation (Senior Executive Couch );. Vistage International, The world’s Leading Chief Executive Organization Year 2015.