Arrayit Corporation (ARYC)

[Alyssa]

Updated by FDA 4/30/20 - Arrayit is still one of twenty-four labs still on the FDA's list of labs "that have notified the 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."

Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notifications submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing.

Access Medical Laboratories Not FDA Authorized H
Arrayit Corporation Not FDA Authorized H
Beaumont Health Not FDA Authorized H
BioDiagnostic Inc. Not FDA Authorized H
Bioreference Laboratories Inc. Not FDA Authorized H
Boston Heart Diagnostics Not FDA Authorized H
Dept of Pathology & Laboratory Medicine @ The Medical Center, Navicent Health Not FDA Authorized H
DLS Research & Ventures Not FDA Authorized H
EDP Biotech Corporation Not FDA Authorized H
Emory Medical Laboratories Not FDA Authorized H
HealthQuest Esoterics Not FDA Authorized H
IMMYLabs Not FDA Authorized H
Lenco Diagnostic LaboratoryNot FDA Authorized H
Mayo Clinic Not FDA Authorized H
Michigan Health Clinics Not FDA Authorized H
National Jewish Health Not FDA Authorized H
Otogenetics Not FDA Authorized H
Progenesis, Inc. Not FDA Authorized H
Rady Children's Hospital - San Diego Not FDA Authorized H
Roseland Community Hospital/American Medical Lab Not FDA Authorized H
Universal Meditech Inc. DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test
Not FDA Authorized H
University of Minnesota Advanced Research and Diagnostic Laboratory
Not FDA Authorized H
Vibrant America Clinical Labs Not FDA Authorized H
VRL Eurofins Not FDA Authorized H
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

So I see even more false and misleading statements being posted here incessently. It boggles the mind.