Emergency Use Authorization (EUA)

High Complexity Molecular-Based Laboratory Developed Tests

On March 31, 2020, the FDA concluded based on the totality of scientific evidence available that molecular-based laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to protect the public health or safety (as described under the Scope of Authorization (Section II)) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3). Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.

Integrity Laboratories began testing for SARS-CoV-2 (COVID-19) under Emergency Use Authorization (EUA) on March 23.

Please direct all inquiries to covid19@integritylaboratories.com for immediate review.

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FDA Authorization Letter   |   FDA EUA Summary

CARES Act Statement