For in vitro diagnostic use

For Over-the-Counter Use

The Healgen Rapid Check™ COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and
influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with symptoms of COVID-19 and influenza. Clinical signs
and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing
themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay, if necessary for patient management. Negative results do not rule out infection with
influenza, SARS-CoV-2 or other pathogens.

This test is not a substitute for visits to a healthcare provider and should not be used to determine any treatments without consulting with a healthcare provider. Individuals who test negative
and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens.

The Healgen Rapid Check™ COVID-19/Flu A&B Antigen Test is intended for non-prescription self-use and/or, as applicable, an adult lay user testing another person 2 years or older in a
non-laboratory setting