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  • About
    • Our Mission
    • Our Vision
    • Our History
    • Meet the Team
    • Meet the SDI Board
    • Testimonials
    • FAQs
    • Contact Us
  • Our Work
    • Set Up A Testing Program
    • SalivaDirect™ Lab Network
    • Our Programs
    • Mobile Laboratories
    • Capacity Building
    • Vending Machines
    • Toolkits
    • Our Partners
  • Support SDI
    • Shape The Future
    • Make a Difference
    • Take Action
  • Clinical Labs
    • Join the Lab Network!
    • Laboratory Designation Process
    • SalivaDirect™ Protocol
    • In Development: SalivaDirect+™
    • SalivaDirect, Inc. Publications
    • International Validation
  • SDI Conference
    • SDI’s Annual Conference
    • Stay Up To Date
  • Lab Portal
  • Donate
  • About
    • Our Mission
    • Our Vision
    • Our History
    • Meet the Team
    • Meet the SDI Board
    • Testimonials
    • FAQs
    • Contact Us
  • Our Work
    • Set Up A Testing Program
    • SalivaDirect™ Lab Network
    • Our Programs
    • Mobile Laboratories
    • Capacity Building
    • Vending Machines
    • Toolkits
    • Our Partners
  • Support SDI
    • Shape The Future
    • Make a Difference
    • Take Action
  • Clinical Labs
    • Join the Lab Network!
    • Laboratory Designation Process
    • SalivaDirect™ Protocol
    • In Development: SalivaDirect+™
    • SalivaDirect, Inc. Publications
    • International Validation
  • SDI Conference
    • SDI’s Annual Conference
    • Stay Up To Date
  • Lab Portal
  • Donate
  • About
    • Our Mission
    • Our Vision
    • Our History
    • Meet the Team
    • Meet the SDI Board
    • Testimonials
    • FAQs
    • Contact Us
  • Our Work
    • Set Up A Testing Program
    • SalivaDirect™ Lab Network
    • Our Programs
    • Mobile Laboratories
    • Capacity Building
    • Vending Machines
    • Toolkits
    • Our Partners
  • Support SDI
    • Shape The Future
    • Make a Difference
    • Take Action
  • Clinical Labs
    • Join the Lab Network!
    • Laboratory Designation Process
    • SalivaDirect™ Protocol
    • In Development: SalivaDirect+™
    • SalivaDirect, Inc. Publications
    • International Validation
  • SDI Conference
    • SDI’s Annual Conference
    • Stay Up To Date
  • Lab Portal
  • Donate
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Important Regulatory Information about SalivaDirect™ 
SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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