Predicate Device

A device that has been FDA cleared via a 510(k) that is used as an compator product.

BNP tests Reducing the time to treatment for patients with heart failure

HPV Tests Helping to allay women's fears about a life-threatening disease

Molecular Diagnostics for Influenza Making point-of-care diagnosis possible

Rapid Influenza Detection Tests Helping doctors decide who needs antivirals, and who needs chicken soup

510(k)