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bioLytical™ Laboratories is a leading developer and manufacturer in rapid HIV diagnostic testing. In 1990 bioLytical™ developed the INSTI™ kit, which is unique, simple-to-use, rapid test for the detection of Human Immunodeficiency Viruses Type 1 (HIV-1). INSTI™ is an in vitro qualitative test and is used with human whole blood, finger stick blood, serum and plasma and takes as little as 60 seconds for completion.
The INSTI™ kit is manufactured in Richmond, BC in a state-of-the-art facility with a fully implemented Quality Control System to ensure the integrity and quality of every test. Our staff of professionals in chemistry, molecular biology, biochemistry, engineering and highly skilled technicians are working together under strict process controls following:
- ISO 9001 and ISO 13485
- Good Manufacturing Practice (GMP)
- Good Laboratory Proactive (GLP) standards
The Research and Development team of INSTI™ HIV-1 Antibody Test is continually watching the recent developments in the field of biotechnology, and researching new diagnostic testing kits. Our regulatory team has upgraded the facility to meet or exceed regulations for the manufacture of medical devices.
bioLytical™ Laboratories is approved by Health Canada for distribution and manufacturing and INSTI™ is in review with Health Canada for approval as a Medical Device for Point of Care use.
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