antigen test kit suppliers

Product Description

The iHealth  COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

Please refer to the downloads section below for a full test facts sheet, FDA-EUA documentation,antigen test kit suppliers  and the instructions for use documents. 

For use with anterior nasal swab specimens

For in vitro Diagnostic Use Only

This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA)

Does not differentiate between SARS-CoV and

SARS-CoV-2.

Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.antigen test kit suppliers  This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.

This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.