InteliSwab™ COVID-19 Rapid Antigen Test EUA OTC 2/Package
InteliSwab™ COVID-19 Rapid Antigen Test, For results anytime and anywhere OTC (Over the Counter) Version, 2 Tests/Box
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Meet InteliSwab™, the COVID-19 rapid antigen test that makes self-testing remarkably simple. It’s so user-friendly, it can be used anytime and anywhere, and requires less than one minute of hands-on time. InteliSwab has received FDA Emergency Use Authorization* for self-testing. You do not need to ship samples to a lab or get a prescription from your healthcare provider. This easy to use self-test requires just 3 key steps: Swab, Swirl and See your result in 30 minutes. There is no assembly required. InteliSwab makes testing so easy, you’ll know you did it right.
Emergency Use Authorization
- Over-the-counter use
- Prescription home use
- Point-of-care use
InteliSwab™ COVID-19 Rapid Antigen Test - Results Anytime and Anywhere
- Detects active COVID-19 infection for both symptomatic and asymptomatic use
- Shallow and gentle nasal swab (lower nostril)
- 98% of untrained, unproctored users found InteliSwab™ easy to use
- Requires less than one minute of hands-on time
- No lab needed and no assembly required
- Get your results in 30 minutes
- No difficult or confusing steps
- No dropper bottle or number of drops required
- No batteries or instruments needed
- Designed in Bethlehem, Pennsylvania by OraSure Technologies, Inc.
- Suitable for ages 15 and up
- Bilingual instructions included in the test kit
Instructions "how the test works"
- Swab: Collect sample from nostrils with gentle, soft swab embedded in test device
- Swirl: Stir test device in tube
- See: Read your results after 30 minutes
- If negative, test again with 24-36 hours between tests
*This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
**For complete testing instructions and interpretation of results, refer to the Instructions for use.
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Download InteliSwab Covid-19 Antigen Documentation
|FDA Letter of Authorization||Positive Result Reference Card|
|Instructions for Use (English)||Product Brochure|
|Instrucciones de uso (español)||Healthcare Provider Fact Sheet|
|Fact Sheet for Individuals||Healthcare Provider IFU|
|Product Net Content UOM||Each|
|Count per Box||2|
|Manufacturer Part Number||1001-061|
|Product Name||InteliSwab™ COVID-19 Rapid Antigen Test|
These are the easiest to administer!