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Skip to main content
  • How to Use
    • For Personal Use
    • For Health Professionals
    • For Schools
    • For Businesses
    • Variant Info
    • Expiration Extension
    • Insurance
    • Web App
    • Press Releases
    • Documentos en Español
  • FAQ
  • Where to Buy

Rapid Test Rx Documents

InteliSwab® COVID-19 Rapid Test Rx

Instructions for Use (English)

Healthcare Provider IFU

Healthcare Provider Fact Sheet

Letter of Authorization

Package Label

Training Video

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This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. The emergency use of 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.