be.well™ COVID-19 Test Kit

Intended Use:

The be.well COVID-19 Test is a rapid molecular test for the qualitative detection of SARS-CoV-2 in individuals suspected of COVID-19 by their healthcare provider. Mid-turbinate nasal samples are collected by sterile Nasal Swabs and used directly in the be.well COVID-19 Test. The test is run using the be.well Analyzer, be.well Assay Buffer, be.well COVID-19 Cartridge, and the be.well Mobile App on a compatible mobile device.

Positive results are indicative of the presence of SARS-CoV-2; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19. The be.well COVID-19 Test is intended for use by clinical professionals or trained operators who are proficient in performing the test in a point-of-care or non-healthcare setting.