Regulatory Strategy

AutoGenomics’ regulatory strategy is consistent with the company’s overall mission and objectives: to offer an innovative and proprietary technology platform to clinical reference labs, specialty clinics, and hospital laboratories.

AutoGenomics has developed instrumentation, reagents, and applications that are at various stages of development and regulatory process.

To ensure product quality, AutoGenomics has established a quality system designed to meet the requirements of the FDA QSR and ISO 13485.