Our Commitment To Quality

Microbix’s ISO 9001:2015 certification, issued by BSI (Certificate No. FM 552929), confirms that our quality management system meets the internationally recognized standard for consistent product and service quality. This certification covers the development, manufacture, and distribution of infectious disease antigens, and supports Microbix’s ability to operate in global markets where ISO 9001 compliance is expected or required.

ISO 13485:2016, issued by BSI (Certificate No. FM 660560), is the leading international standard for QMS specific to medical device manufacturers. This certification covers the design, development, manufacture, and distribution of sample transport media, Quality Assessment Products (QAPs) of infectious disease agents for proficiency testing, validation and verification panels, and clinical quality controls, enabling Microbix to supply regulated healthcare and diagnostics markets worldwide.

Issued under the Medical Devices Regulations of Canada’s Food and Drugs Act, this Medical Device Establishment Licence (No. 12336) authorizes Microbix to manufacture Class I medical devices for distribution within Canada, across two licensed facilities in Mississauga, Ontario. It demonstrates compliance with Health Canada’s regulatory framework and supports Microbix’s ability to supply diagnostic products to Canadian clinical laboratories and healthcare institutions.

This CE marking notification authorizes Microbix’s REDx STI controls including a Mycoplasma genitalium positive control and an STI negative control — for sale across Belgium and other EU/EEA Member States. Issued via Obelis S.A. under EU Directive 98/79/EC, it enables these NAAT-based quality controls to be used in European clinical and diagnostic laboratories.

This CE marking notification, completed through Obelis S.A. under EU Directive 98/79/EC, authorizes Microbix’s REDx FLOQ SARS-CoV-2 antigen swab controls covering positive and negative swab controls for immunodiagnostic assays for distribution across Belgium and other EU/EEA Member States. These products support laboratory performance monitoring for SARS-CoV-2 antigen detection workflows throughout Europe.

This CE marking notification authorizes four of Microbix’s REDx SARS-CoV-2 nucleic acid controls — liquid positive and negative controls, and swab positive and negative controls — for distribution across Belgium and other EU/EEA Member States. Issued through Obelis S.A. under EU Directive 98/79/EC, these products support molecular diagnostic laboratories monitoring SARS-CoV-2 nucleic acid testing performance throughout Europe.