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InteliSwab™ Covid-19 EUA Antigen Test Kit, 2 Tests/Box

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SKU:
OS1001-0616
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Description

InteliSwab™ COVID-19 Antigen EUA Authorized Rapid Test Kit

IN STOCK - SHIPS WITHIN 24 HOURS VIA UPS

REMARKABLY SIMPLE COVID-19 TESTING

Now authorized for over-the-counter use, prescription home use and point-of-care use (POC).

InteliSwabTM puts you in control

InteliSwab™ makes it easier for individuals with or without symptoms to test themselves anytime, anywhere, and take all the necessary precautions if they test positive. With Emergency Use Authorization for over-the-counter use, prescription home use and point-of-care use, InteliSwab™ can meet the needs of any employer, university, physician office, public health testing site or venue large or small.

SMART SCIENCE MADE SIMPLETM

  • There are no confusing steps, no batteries and no mailing to labs
  • You just swab your nostrils with the gentle swab, swirl it in the tube, and see results in minutes
  • It’s just that simple. That's the power of InteliSwabTM

FDA APPROVALS

  • 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.
  • 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.

Designed by Trusted Innovators

InteliSwabTM is designed and developed in Bethlehem, Pennsylvania by OraSure, a leading innovator in diagnostic testing for infectious disease - and the creator of the first in-home HIV test. Now, OraSure has leveraged its expertise to develop COVID-19 testing solutions.

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
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Additional Information

Per Each:
2
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