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Saturday, May 02, 2020 10:07:57 PM
http://edpbiotech.com/edp-biotech-fda-notification-and-listing-for-covid-19-serology-antibody-testing/
The commercial manufacturers and laboratories listed below have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not reviewed the validation of tests offered by these developers, who may not be pursuing EUAs, and is including this list here to provide transparency regarding the notifications submitted to FDA.
Laboratory Notifications:
Arrayit Corporation
Beaumont Health
Boston Heart Diagnostics
DLS Research & Ventures
EDP Biotech Corporation
Emory Medical Laboratories
IMMYLabs
Mayo Clinic
Michigan Health Clinics
http://edpbiotech.com/edp-biotech-fda-notification-and-listing-for-covid-19-serology-antibody-testing/
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