Respiratory Test Kit InteliSwab® COVID-19 Rapid Test (OTC) 2 Tests per Kit, 24 Kits per Box CLIA Waived

Features

• The InteliSwab COVID-19 Rapid Test OTC is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older
• This test is authorized for for individuals with symptoms of COVID-19 within the first seven (7) days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests
• The InteliSwab® COVID-19 Rapid Test does not differentiate between SARS-CoV-1 and SARS-CoV-2
• Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
• Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease
• Use at home or anywhere there is a flat surface
• No professional supervision or video consultation required

More Information

• InteliSwab COVID-19 Rapid Test FDA EUA Letter Jan 2023
• InteliSwab COVID-19 Rapid Test IFU Feb 2023
• InteliSwab COVID-19 Rapid Test HCP IFU
• InteliSwab COVID-19 Rapid Test HCP Fact Sheet
• InteliSwab Shelf-Life Extension Notification Sep 2023
• InteliSwab COVID-19 Rapid Test Box Label