A device is designated Class II when general controls are insufficient to ensure that the it will be safe and effective. Class II devices are subject to special controls including the requirement to submit a 510(k) or premarket notification application.
Class II Device
Share / Follow
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