Genabio Diagnostics Inc.
iHealth - COVID-19 Antigen Rapid Test
Intended use: iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. 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. 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.
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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.
Authorized for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older.
Only for use under the Food and Drug Administration’s Emergency Use Authorization.
iHealth® COVID-19 Antigen Rapid
Authorized for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older.
Only for use under the Food and Drug Administration’s Emergency Use Authorization.
iHealth® COVID-19 Antigen Rapid