THIS ITEM WILL SHIP IN OCTOBER WHEN THE MANUFACTURER RELEASES THIS NEW PRODUCT.  EXACT OCTOBER DATE IN NOT KNOWN.

InteiliSwab COVID-19 Antigen Rapid Test from OraSure gets FDA Authorization

REMARKABLY SIMPLE COVID-19 TESTING

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

InteliSwab^TM 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 SIMPLE^TM

• 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 InteliSwab^TM

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

InteliSwab^TM 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