1108-13351 Commerce Parkway
V6V 2X7 Richmond, BC
Phone: +1 604 2046784
Fax: +1 604 2448399
Department/ Name Address
Business Development 1108-13351 Commerce Parkway, V6V 2X7 Richmond, BC, Canada, Phone: +1 604 2046784, Mobile: +1-778-855-1720, Fax: +1 604 2448399, http://www.biolytical.com
Number of employees 20-49
Sales volume 1-9 Mio US $
Export content > 75%
Year of foundation 2002
Area of business Diagnostics
About bioLytical� LABORATORIES
The INSTI Kit is manufactured in a state-of-the-art facility with a fully implemented Quality Control System to ensure the integrity and quality of every test. The staff consists of trained professionals in engineering, chemistry and pharmacy, and highly skilled technicians all working together under strict process controls, following Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) standards.
The manufacturing facility contains a dedicated Quality Assurance (Biological) Laboratory and Production Laboratory equipped with automated and duly calibrated process and testing instruments. The Quality Management System is ISO 9001 and ISO 13485 certified.
All raw materials and processed kit components are rigorously inspected and tested to ensure they meet strict quality guidelines. At each step of the manufacturing process there are checks to ensure continued quality control. Finally, before any product is released into inventory, lot release testing protocols are completed and a value added third party testing program is offered.
The color developer used in the INSTI is a proprietary formulation allowing us to control quality in our own laboratories. As a result we do not rely on outside suppliers for this critical component of the INSTI.
The Research and Development team continues to develop and improve the INSTI HIV-1&2 Antibody Test Kit to reflect recent developments in the field of biotechnology. Our regulatory team has upgraded the facility to meet or exceed regulations for the manufacture of medical devices. Our ultimate goal is to provide you with products and service that will exceed your requirements. New products to be launched in 2009 will the world”s first one minute rapid tests for Malaria, TB, Syphylis, Myoglobin, CK-MB, Troponin, Pro-BNP etc