The Eli Cortisol Test is a wellness product as described by FDA's guidance- General Wellness: Policy for Low Risk Devices and does not require FDA registration or approval.
However, the company has established a rigorous quality management system, following FDA's requirements for post-market activities for medical devices.
In a nutshell, although Eli Cortisol is not a medical device, we go above and beyond to ensure a high quality product and as far as following medical device requirements for low-risk devices.