Thursday, June 25, 2020 9:26:13 AM
Q: What laboratories are offering serology tests under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 6/23)
A: Arrayit Corporation.
....While laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing...
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