Respiratory Test Kit InteliSwab
COVID-19 Rapid Test (OTC) 2 Tests per Kit,
24 Kits per Box CLIA Waived
Orasure 1001-0622

Respiratory Test Kit InteliSwab
COVID-19 Rapid Test (OTC) 2 Tests per Kit,
24 Kits per Box CLIA Waived
Orasure 1001-0622

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 direct anterior nasal (nares) swab samples from individuals aged 18 years or older with symptoms of COVID-19 within the first 7 days of symptom onset This test is authorized for non-prescription home use with adult-collected nasal 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 18 years or older, or adult collected anterior nasal 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 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

Manufacturer # 1001-0622 Brand InteliSwab® Manufacturer Orasure Technologies Country of Origin United States Application Respiratory Test Kit CLIA Classified CLIA Waived Contents 1 Each Kit contains: (2) Pouches with Single-use Test Device and Tube with Developer Fluid, IFU, Positive Result Reference Card, Test Stand HCPCS U0002 Number of Tests 2 Tests per Kit, 24 Kits per Box

Purchase Program Type Standard Purchase Reading Type Visual Read Sample Type Nasal Swab Sample Specialty Immunoassay Test Format Test Device Format Test Kit Type Rapid Test Method Lateral Flow Immunoassay Test Name COVID-19 Rapid Test (OTC) Test Type Antigen Detection Time to Results 30 to 40 Minute Time to Results UNSPSC Code 41116205