Attention: Clinical Laboratories

Please share this announcement with the following:

             Medical Director, Laboratory Services

             Administrative Director and Managers, Laboratory Services

On Thursday, June 4, 2020, the U.S. Food and Drug Administration (FDA) posted Independent Evaluations of COVID-19 Serological Tests.

Key points:

  1. The document includes performance data for COVID-19 serology tests that have been evaluated through the Independent Evaluation program.
  2. The document indicates those test that have been authorized, denied, revoked, or otherwise removed from the ‘notified test’ list.
  3. Additional tests and data will be added to this document as evaluations are completed.

Read the entire document here. Independent Evaluations of Covid 19 Serology

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