+1803294983432
customer.service@microbix.com
Our Commitment
Our Commitment To Quality
Microbix strives to meet and exceed our customer expectations. Management and employees are committed to comply with customer and regulatory requirements for continuous improvement in everything we do. We apply our quality management system to all relevant activities. Senior Management reviews our Quality Management System on a regular basis to ensure its continued effectiveness.
Quality in Manufacturing
Quality is a process that ensures customers receive products that meet or exceed their needs and expectations. Our quality management system takes into consideration regulatory requirements that are applicable to the type of products we manufacture and industries we serve. Our manufacturing starts from qualified master and working cell and seed banks.
Manufacturing operations are protected by the cleanroom environment with strict cleaning regimen, routine environmental monitoring and are executed by employees highly experienced with cell and tissue culture techniques. Our manufacturing site is certified to the most current ISO standards.
BSI-ISO 9001-2015
Microbix Biosystems is certified under ISO 9001:2015 by BSI (Certificate No. FM 552929), demonstrating that its quality management system meets international standards for the development, manufacture, and distribution of infectious disease antigens. This certification, valid through September 2027, is one of several credentials underpinning Microbix’s commitment to quality across its global operations.
ISO-9001-2015-quality-management.pdf
BSI ISO 13485 2016
Microbix Biosystems holds BSI Certificate No. FM 660560, confirming compliance with ISO 13485:2016 for the design, development, manufacture, and distribution of sample transport media and infectious disease Quality Assessment Products. Valid through September 2027, it reflects Microbix’s adherence to the medical device industry’s highest quality standards.
ISO-13485-2016-quality-management.pdf
Health Canada Licence 12336
Microbix Biosystems holds Health Canada Medical Device Establishment Licence No. 12336, issued under the Medical Devices Regulations of the Food and Drugs Act. Covering Class II device manufacturing for distribution at its Mississauga facilities, this licence confirms Microbix meets Canadian regulatory requirements for complaint handling, distribution records, recalls, and corrective action procedures.
Health-Canada-Licence-12336-quality-management.pdf
Obelis Certificate EZ 8047 2019
Microbix Biosystems holds Obelis Certificate EZ 8047 2019, issued by Obelis S.A. as EU Authorised Representative, covering the REDx Controls HPV product line — including HPV 16, 18, and 45 positive controls and an HPV negative control — for use as unassayed IVD controls in nucleic acid amplification testing across European markets.
Obelis-Certificate-EZ 8047-2019.pdf
Obelis Certificate EZ 9873 2020
Microbix Biosystems holds Obelis Certificate EZ 9873 2020, issued by Obelis S.A. as EU Authorised Representative, covering the REDx STI control product line — including a Mycoplasma genitalium positive control and an STI negative control — for use as unassayed IVD controls in nucleic acid amplification testing for sexually transmitted infections across European markets.
Obelis-Certificate-EZ 9873-2020.pdf
Obelis Certificate EZ 0734 2021
Microbix Biosystems holds Obelis Certificate EZ 0734 2021, issued by Obelis S.A., the EU Authorised Representative for Microbix’s products in the European market. This certificate supports Microbix’s compliance with European regulatory requirements for the distribution of its infectious disease diagnostic products across EU member states.
Obelis-Certificate-EZ 0734-2021.pdf
Obelis Certificate EZ 9317 2020
Microbix Biosystems holds Obelis Certificate EZ 9317 2020, issued by Obelis S.A. as EU Authorised Representative, covering the REDx SARS-CoV-2 control product line — including positive and negative controls in both liquid and swab formats — for use as unassayed IVD controls in nucleic acid assays detecting SARS-CoV-2 across European markets.
Obelis-Certificate-EZ 9317-2020.pdf
BSI-ISO IVDR 780538-R000
Microbix Biosystems holds EU Quality Management System Certificate No. IVDR 780538 R000, issued by BSI under the EU In Vitro Diagnostic Regulation (EU) 2017/746. Covering in vitro diagnostic controls for monitoring the detection of infectious agents, this certification confirms Microbix’s quality system meets European regulatory requirements for IVD devices and is valid through September 2029.
BSI-ISO-IVDR-780538-R000.pdf
Obelis Certificate EZ 8047 2019
Microbix Biosystems holds Obelis Certificate EZ 8047 2019, issued by Obelis S.A. as EU Authorised Representative, covering the REDx Controls HPV product line — including HPV 16, 18, and 45 positive controls and an HPV negative control — for use as unassayed IVD controls in nucleic acid amplification testing across European markets.
Obelis-Certificate-EZ 8047-2019.pdf
Obelis Certificate EZ 9873 2020
Microbix Biosystems holds Obelis Certificate EZ 9873 2020, issued by Obelis S.A. as EU Authorised Representative, covering the REDx STI control product line — including a Mycoplasma genitalium positive control and an STI negative control — for use as unassayed IVD controls in nucleic acid amplification testing for sexually transmitted infections across European markets.
Obelis-Certificate-EZ 9873-2020.pdf
Obelis Certificate EZ 0734 2021
Microbix Biosystems holds Obelis Certificate EZ 0734 2021, issued by Obelis S.A., the EU Authorised Representative for Microbix’s products in the European market. This certificate supports Microbix’s compliance with European regulatory requirements for the distribution of its infectious disease diagnostic products across EU member states.
Obelis-Certificate-EZ 0734-2021.pdf
Obelis Certificate EZ 9317 2020
Microbix Biosystems holds Obelis Certificate EZ 9317 2020, issued by Obelis S.A. as EU Authorised Representative, covering the REDx SARS-CoV-2 control product line — including positive and negative controls in both liquid and swab formats — for use as unassayed IVD controls in nucleic acid assays detecting SARS-CoV-2 across European markets.
Obelis-Certificate-EZ 9317-2020.pdf
Obelis Certificate EZ 8047 2019
Microbix Biosystems holds Obelis Certificate EZ 8047 2019, issued by Obelis S.A. as EU Authorised Representative, covering the REDx Controls HPV product line — including HPV 16, 18, and 45 positive controls and an HPV negative control — for use as unassayed IVD controls in nucleic acid amplification testing across European markets.
Obelis-Certificate-EZ 8047-2019.pdf
Obelis Certificate EZ 9873 2020
Microbix Biosystems holds Obelis Certificate EZ 9873 2020, issued by Obelis S.A. as EU Authorised Representative, covering the REDx STI control product line — including a Mycoplasma genitalium positive control and an STI negative control — for use as unassayed IVD controls in nucleic acid amplification testing for sexually transmitted infections across European markets.
Obelis-Certificate-EZ 9873-2020.pdf
Obelis Certificate EZ 0734 2021
Microbix Biosystems holds Obelis Certificate EZ 0734 2021, issued by Obelis S.A., the EU Authorised Representative for Microbix’s products in the European market. This certificate supports Microbix’s compliance with European regulatory requirements for the distribution of its infectious disease diagnostic products across EU member states.
Obelis-Certificate-EZ 0734-2021.pdf
Obelis Certificate EZ 9317 2020
Microbix Biosystems holds Obelis Certificate EZ 9317 2020, issued by Obelis S.A. as EU Authorised Representative, covering the REDx SARS-CoV-2 control product line — including positive and negative controls in both liquid and swab formats — for use as unassayed IVD controls in nucleic acid assays detecting SARS-CoV-2 across European markets.
Obelis-Certificate-EZ 9317-2020.pdf
BSI-ISO 9001-2015
Microbix Biosystems is certified under ISO 9001:2015 by BSI (Certificate No. FM 552929), demonstrating that its quality management system meets international standards for the development, manufacture, and distribution of infectious disease antigens. This certification, valid through September 2027, is one of several credentials underpinning Microbix’s commitment to quality across its global operations.
ISO-9001-2015-quality-management.pdf
BSI ISO 13485 2016
Microbix Biosystems holds BSI Certificate No. FM 660560, confirming compliance with ISO 13485:2016 for the design, development, manufacture, and distribution of sample transport media and infectious disease Quality Assessment Products. Valid through September 2027, it reflects Microbix’s adherence to the medical device industry’s highest quality standards.
ISO-13485-2016-quality-management.pdf
Health Canada Licence 12336
Microbix Biosystems holds Health Canada Medical Device Establishment Licence No. 12336, issued under the Medical Devices Regulations of the Food and Drugs Act. Covering Class II device manufacturing for distribution at its Mississauga facilities, this licence confirms Microbix meets Canadian regulatory requirements for complaint handling, distribution records, recalls, and corrective action procedures.
Health-Canada-Licence-12336-quality-management.pdf
BSI-ISO IVDR 780538-R000
Microbix Biosystems holds EU Quality Management System Certificate No. IVDR 780538 R000, issued by BSI under the EU In Vitro Diagnostic Regulation (EU) 2017/746. Covering in vitro diagnostic controls for monitoring the detection of infectious agents, this certification confirms Microbix’s quality system meets European regulatory requirements for IVD devices and is valid through September 2029.
BSI-ISO-IVDR-780538-R000.pdf
Distributors
Partnerships
Copan Group
Australian Centre for the Prevention of Cervical Cancer (ACPCC)
National Centre of Infectious and Parasitic Diseases (NCIPD)
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