List of COVID19 tests
Hi all,
did you see the APHL Alert #28 that listed the latest EUAs for tests? Sorry the table formatting is not good.
Additional EUAs Issued by FDA
A number of EUAs have been issued in the past few days. A full table of all authorizations follows. More information including instructions for use can be found at FDA's EUA site.
did you see the APHL Alert #28 that listed the latest EUAs for tests? Sorry the table formatting is not good.
Additional EUAs Issued by FDA
A number of EUAs have been issued in the past few days. A full table of all authorizations follows. More information including instructions for use can be found at FDA's EUA site.
| Date EUA Issued | Manufacturer | Diagnostic (Letter of Authorization)
| 3/23/2020 | Mesa Biotech Inc. | Accula SARS-Cov-2 Test
| 3/23/2020 | BioFire Defense, LLC | BioFire COVID-19 Test
| 3/20/2020 | Cepheid | Xpert Xpress SARS-CoV-2 test
| 3/20/2020 | Primerdesign Ltd. | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
| 3/19/2020 | GenMark Diagnostics, Inc. | ePlex SARS-CoV-2 Test
| 3/19/2020 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct assay
| 3/18/2020 | Abbott Molecular | Abbott RealTime SARS-CoV-2 assay
| 3/17/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest SARS-CoV-2 rRT-PCR
| 3/17/2020 | Quidel Corporation | Lyra SARS-CoV-2 Assay
| 3/16/2020 | Laboratory Corporation of America (LabCorp) | COVID-19 RT-PCR Test
| 3/16/2020 | Hologic, Inc. | Panther Fusion SARS-CoV-2
| 3/13/2020 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit
| 3/12/2020 | Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2
| 2/29/2020 | Wadsworth Center, New York State Department of Public Health's (CDC) | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel
| 2/04/2020 | Centers for Disease Control and Prevention's (CDC) | CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
| 3/23/2020 | Mesa Biotech Inc. | Accula SARS-Cov-2 Test
| 3/23/2020 | BioFire Defense, LLC | BioFire COVID-19 Test
| 3/20/2020 | Cepheid | Xpert Xpress SARS-CoV-2 test
| 3/20/2020 | Primerdesign Ltd. | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
| 3/19/2020 | GenMark Diagnostics, Inc. | ePlex SARS-CoV-2 Test
| 3/19/2020 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct assay
| 3/18/2020 | Abbott Molecular | Abbott RealTime SARS-CoV-2 assay
| 3/17/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest SARS-CoV-2 rRT-PCR
| 3/17/2020 | Quidel Corporation | Lyra SARS-CoV-2 Assay
| 3/16/2020 | Laboratory Corporation of America (LabCorp) | COVID-19 RT-PCR Test
| 3/16/2020 | Hologic, Inc. | Panther Fusion SARS-CoV-2
| 3/13/2020 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit
| 3/12/2020 | Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2
| 2/29/2020 | Wadsworth Center, New York State Department of Public Health's (CDC) | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel
| 2/04/2020 | Centers for Disease Control and Prevention's (CDC) | CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
we are working on pulling together the associated coding for these and provide some guidance documentation.
Riki