"So why the f is the FDA taking so long to approve
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Posted On: 12/08/2020 9:44:35 AM
"So why the f is the FDA taking so long to approve either Abbott or Innova."
The Abbott rapid antigen test was approved by the FDA on 8/26/20.
https://www.fda.gov/media/141567/download
The 8 antigen test with EUAs from the FDA (as of 12/8/20).
12/07/2020 Luminostics, Inc. - Clip COVID Rapid Antigen Test
10/23/2020 Celltrion USA, Inc. - Sampinute COVID-19 Antigen MIA
10/13/2020 Access Bio, Inc. - CareStart COVID-19 Antigen test
10/02/2020 Quidel Corporation - Sofia 2 Flu + SARS Antigen FIA
08/26/2020 Abbott Diagnostics Scarborough, Inc. - BinaxNOW COVID-19 Ag Card
08/18/2020 LumiraDx UK Ltd. - LumiraDx SARS-CoV-2 Ag Test
07/23/2020 Becton, Dickinson and Company (BD) - BD Veritor System for Rapid Detection of SARS-CoV-2
07/17/2020 Quidel Corporation - Sofia SARS Antigen FIA
The Abbott rapid antigen test was approved by the FDA on 8/26/20.
https://www.fda.gov/media/141567/download
The 8 antigen test with EUAs from the FDA (as of 12/8/20).
12/07/2020 Luminostics, Inc. - Clip COVID Rapid Antigen Test
10/23/2020 Celltrion USA, Inc. - Sampinute COVID-19 Antigen MIA
10/13/2020 Access Bio, Inc. - CareStart COVID-19 Antigen test
10/02/2020 Quidel Corporation - Sofia 2 Flu + SARS Antigen FIA
08/26/2020 Abbott Diagnostics Scarborough, Inc. - BinaxNOW COVID-19 Ag Card
08/18/2020 LumiraDx UK Ltd. - LumiraDx SARS-CoV-2 Ag Test
07/23/2020 Becton, Dickinson and Company (BD) - BD Veritor System for Rapid Detection of SARS-CoV-2
07/17/2020 Quidel Corporation - Sofia SARS Antigen FIA
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