As the COVID-19 pandemic evolves, requirements to test continue to evolve. CardiAI will ensure that its assessments meet evolving standards. But it is impossible to predict every possible change, or when it might occur. Health care providers and their patients should be aware of this risk beyond how CardiAI can control. CardiAI meets all Provincial regulatory laboratory requirements met. These are Laboratory Developed Tests developed, validated, and used for inhouse pathology and diagnostic purposes. This is intended for use only by the laboratory entity where they are developed, unlike the majority of commercially marketed laboratory tests manufactured by medical device companies and sold to laboratories, hospitals or physicians’ offices in interstate commerce, and must be cleared or approved by the Food and Drug Administration (FDA) through FDA-EUA and Health Canada through Interim Order. Laboratories that develop these “in-house” diagnostic tests, either create the reagents themselves or purchase reagents from outside vendors, and then develop their own proprietary test. These tests will be sold to other laboratories, hospitals, or doctors subject to HC/FDA approval or clearance processes. These tests are pending Regulatory Approvals.
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