INFORMATION FOR

COVID-19 ASSURE KITS

Image.jpeg

BioLab Sciences is distributing Assure COVID-19 test kits. For more information, please click on the buttons below to open up the documents.

  • This test has not been FDA cleared or approved;

  • This test has been authorized by FDA under an EUA for use by authorized laboratories . This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation;

  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and

  • This test 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 authorization is terminated or revoked sooner.

© 2020 by BioLab Sciences Inc.