Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test Receiving EUA Mar 31 Becton Dickinson BD Veritor System for Rapid Detection of SARS-CoV-2(a) for serial use Mar 31 Abbott BinaxNOW COVID-19 Ag Card 2 Home Test(a) for home use Mar 31 Abbott BinaxNOW COVID-19 Antigen Self Test(a) for serial use Mar 31 Quidel QuickVue At-Home OTC COVID-19 Test(a) for serial use Mar 31 NeuMoDx Molecular NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay Mar 29 Amazon Amazon Real-Time RT-PCR Test Mar 29 Becton Dickinson BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B(a) Mar 26/May 14,2020 Hologic Aptima SARS-CoV-2 assay reissued for pooling and screening uses Mar 25 Siemens Healthineers Atellica IM SARS-CoV-2 IgG antibody test(s) Mar 23 Twist Bioscience SARS-CoV-2 NGS Assay Mar 23 Beckman Coulter Access SARS-CoV-2 IgG II rapid antibody test(s) Mar 22/Oct 1, 2020 Tempus Labs, Inc. iC SARS-CoV2 test/Reissued for home collection Mar 19/Aug 31, 2020 Color Health Color COVID-19 Self-Swab Collection Kit/Reissued for home collection and screening Mar 19 Color Health Color COVID-19 Self-Swab Collection Kit DTC for home collection and screening Mar 19 Color Health […]