The Vessel wellness test card falls under the general health and wellness guidelines of the FDA and therefore we are not seeking approval for it. We are seeking approval for our blood based at-home COVID-19 antibody test and have recently completed our clinical trial.
Our Wellness cards are considered a Class I non invasive medical device. The primary distinction for this classification is our use of urine (non invasive specimen collection) vs. our choice not to use blood (which is an invasive specimen collection).
