InvestorsHub Logo

drugmanrx

08/12/20 9:31 PM

#92816 RE: TedJ #92815

Got to hand it to you, I thought I did pretty thorough DD, but you got me beat.

Hats off.

RPR

08/12/20 9:40 PM

#92817 RE: TedJ #92815

Thanks

TedJ

08/13/20 11:45 AM

#92838 RE: TedJ #92815

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None (originally over 100 but EUA was revoked 7/21/20) -- Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2