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  1. Coronavirus (COVID-19) and Medical Devices

Serology/Antibody Tests: FAQs on Testing for SARS-CoV-2

This page provides answers to frequently asked questions related to serology/antibody tests for SARS-CoV-2.

This section includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised). In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.

For a directory of FAQs related to SARS-CoV-2 testing, see FAQs on Testing for SARS-CoV-2.

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