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).
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
- 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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