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Thursday, 04/23/2020 10:42:49 AM

Thursday, April 23, 2020 10:42:49 AM

Post# of 205105
Laboratories that have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D:
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.

Search:
Laboratory Authorization Status Settings for Use1
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

https://www.hqesoterics.com/covid-19

Serving Our Community During COVID-19
As a state of the art full-service reference laboratory specializing in rapid routine, toxicology, and molecular testing, we knew that the right thing to do was to step up to this unprecedented challenge, and play our part in stemming the spread of this global pandemic. Now, more than ever, our philosophy of getting accurate medical information into the hands of the right healthcare professionals, quickly, so they can take action, is absolutely crucial.
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We are proud to provide COVID-19 diagnostic testing via serological antibody and qPCR within 24 - 48 hours. We also provide Coronavirus antibody testing as well. Contact us today if you are a medical facility in need of rapid testing results for your patients. We are continuing to scale our testing capacity in the midst of this crisis to be able to meet the demands of the communities we serve.
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In response to the ongoing coronavirus outbreak, we have worked tirelessly to facilitate the rapid collection and interpretation of data, using a fast and highly sensitive instrumentation from top diagnostic manufacturers. HealthQuest Esoterics is a COLA certified, CLIA compliant medical testing laboratory, capable of performing such high complexity tests in an effective and efficient manner. We follow all standard confirmatory testing and reporting guidelines according to the appropriate public health authorities.