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Our Manufacturing Standards

AsureQuality Diagnostics has many years of experience manufacturing products for the animal health sector and for the medical research community.

We comply with Good Manufacturing Practice (GMP) principles and hold a USDA licence (No 582A, for Mycobacterium Bovis Gamma Interferon test kits for cattle, for Mycobacterium Bovis Gamma Interferon test kits for non-human primates and Mycobacterium Paratuberculosis Antibody test kits) and a APVMA licence (No 1085, Category 1 (immunobiologicals and/or sterile veterinary preparations).

We are certified under ISO9001:2015 and are working towards the ISO13485:2016 certification to be obtained by early 2019 to enable us to contract manufacture IVDs.  

We are fully engaged in continuous improvement to optimise systems and procedures to be able to address the ever-changing regulatory requirements and meet our customer needs.

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