Comprehensive regulatory support for diagnostic cartridge and instrument development including FDA, IVDR, and TGA approval guidance. Leverages proven expertise in navigating international regulatory requirements.
Manufactured by
Axxin
Australia
Axxin provides diagnostics instruments and systems for IVD and non-IVD applications. The company's goal is to take the cost and complexity out of point of care diagnostics and near patient applications. Axxin has extensive experience in instrument design, industrial design, sensor technologies and has applied these to molecular and lateral flow applications. The company is ISO 13485 accredited.
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