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TedJ

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TedJ

Re: TedJ post# 92815

Thursday, 08/13/2020 11:45:28 AM

Thursday, August 13, 2020 11:45:28 AM

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https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

Authorized under EUAs as of 8/13/20:

138 Virus tests -- Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2

35 Labs -- Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests

2 Antigen tests -- Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2

37 Antibody tests -- Individual EUAs for Serology Tests for SARS-CoV-2

None (originally over 100 but EUA was revoked 7/21/20) -- Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
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