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Press Releases

  • INTELISWAB® COVID-19 RAPID TESTS RECEIVE U.S. FDA AUTHORIZATION FOR PEDIATRIC USE AND COMPANY LAUNCHES NEW INTELISWAB® CONNECT REPORTING APP
  • U.S. FDA AUTHORIZES INTELISWAB® COVID-19 RAPID TESTS FOR OTC SINGLE-USE, AT-HOME TESTING FOR SYMPTOMATIC PEOPLE AND ACCEPTS DATA FOR DELTA VARIANT DETECTION
  • ORASURE TO RECEIVE UP TO $13.6 MILLION FROM BIOMEDICAL ADVANCED RESEARCH DEVELOPMENT AUTHORITY TO SUPPORT INTELISWAB® COVID-19 RAPID TEST 510(K) CLEARANCE AND CLIA WAIVER
  • ORASURE RECEIVES $205 MILLION PROCUREMENT CONTRACT FOR INTELISWAB® FROM THE DEFENSE LOGISTICS AGENCY TO SUPPLY OVER-THE-COUNTER (OTC) KITS AS PART OF NATIONAL PANDEMIC RESPONSE
  • ORASURE TECHNOLOGIES RECEIVES THREE EMERGENCY USE AUTHORIZATIONS FOR ITS COVID-19 RAPID ANTIGEN TESTS FOR NON-PRESCRIPTION (OTC), PROFESSIONAL AND PRESCRIPTION USE
  • ORASURE TECHNOLOGIES SUBMITS COVID-19 RAPID ANTIGEN PRESCRIPTION HOME SELF-TEST AND PROFESSIONAL TEST TO FDA FOR EMERGENCY USE AUTHORIZATION

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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.