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Each Kit contains: (2) Pouches with Single-use Test Device and Tube with Developer Fluid
Contents 1
IFU
HCPCS
Positive Result Reference Card
Number of Tests
Test Stand
Product Dating
U0002
Purchase Program Type
2 Tests per Kit
Reading Type
24 Kits per Box
Sample Type
SLI Medical Acceptable Dating: we will ship >= 90 days
Specialty
Visual Read
Test Format
Nasal Swab Sample
Test Kit Type
Test Device Format
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
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
