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COVID-19 TEST UPDATES Company Name


Abbott Molecular Inc. Abbott Molecular Inc. Access Bio, Inc.


Agena Bioscience, Inc.


Applied BioCode, Inc. Atila BioSystems, Inc.


BayCare Laboratories, LLC


Last Updated (and Original Date EUA Issued)


6/10/2021 (3/4/2021)


Name of Test Alinity m Resp-4-Plex


12/23/2020 (5/11/2020) Alinity m SARS-CoV-2 assay 2/5/2021 (7/7/2020)


6/8/2021 (6/15/2020) CareStart COVID-19 MDx RT-PCR 5/4/2021 (10/26/2020) MassARRAY SARS-CoV-2 Panel BioCode SARS-CoV-2 Assay


12/28/2020 (4/10/2020) iAMP COVID-19 Detection Kit 1/28/2021 (8/31/2020) BayCare SARS-CoV-2 RT PCR Assay


Becton, Dickinson and Company (BD) 4/29/2021 (4/8/2020) BD SARS-CoV-2 Reagents for BD MAX System


Becton, Dickinson and Company (BD) 4/29/2021 (2/10/2021) BD SARS-CoV-2/Flu for BD MAX System BioCore Co., Ltd.


BioFire Defense, LLC BioFire Diagnostics, LLC Bio-Rad Laboratories, Inc Bio-Rad Laboratories, Inc.


Bio-Rad Laboratories, Inc.


Centers for Disease Control and Prevention (CDC)


Cepheid Cepheid Cepheid Cepheid


Cue Health Inc. DiaCarta, Inc DiaCarta, Inc.


DiaSorin Molecular LLC Enzo Life Sciences, Inc. Euroimmun US, Inc.


Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)


Fluidigm Corporation Fosun Pharma USA Inc. Gencurix, Inc.


Grifols Diagnostic Solutions Inc. Guardant Health, Inc. Hologic, Inc. Hologic, Inc.


Hologic, Inc. Illumina, Inc.


Laboratory Corporation of America (Labcorp)


Laboratory Corporation of America (LabCorp)


LGC, Biosearch Technologies Luminex Molecular Diagnostics, Inc. LumiraDx UK Ltd.


12/18/2020 (5/21/2020) BioCore 2019-nCoV Real Time PCR Kit 6/17/2021 (3/23/2020) BioFire COVID-19 Test 4/27/2021 (10/2/2020) 12/9/2020 (5/1/2020) 5/6/2021 (1/15/2021)


Type of Test


Real-time RT-PCR, Multi-analyte Real-time RT-PCR, Pooling, Screening Real-time RT-PCR


RT-PCR, chip array and MALDI-TOF Mass Spec.


RT-PCR, Pooling


RT, Isothermal amplification Real-time RT-PCR, Pooling


Real-time RT-PCR, Serial Screening


Real-time RT-PCR, Multi-analyte Real-time RT-PCR


RT, Nested multiplex PCR, Pooling


Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit


2/11/2021 (2/11/2021) Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit


1/8/2021 (7/2/2020)


Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay


4/20/2021 (11/27/2020) Xpert Omni SARS-CoV-2


1/27/2021 (9/24/2020) Xpert Xpress SARS-CoV-2/Flu/RSV 1/7/2021 (3/20/2020)


Xpert Xpress SARS-CoV-2 test


12/23/2020 (12/23/2020) Xpert Xpress SARS-CoV-2 DoD 3/26/2021 (6/10/2020) Cue COVID-19 Test 2/3/2021 (4/8/2020)


RT-droplet PCR Real-time RT-PCR


Authorized Settings


H, M H, M H H


H H H


H, M


H, M H


H, M


BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) RT, Nested multiplex PCR, Multi-analyte H, M, W Bio-Rad SARS-CoV-2 ddPCR Test


H H


Real-time RT-PCR, Multi-analyte Real-time RT-PCR, Multi-analyte Real-time RT-PCR


Real-time RT-PCR, Multi-analyte Real-time RT-PCR


Real-time RT-PCR, Pooling QuantiVirus SARS-CoV-2 Test kit Simplexa COVID-19 Direct assay


EURORealTime SARS-Cov-2 FTD SARS-CoV-2


H H


H, M, W H, M, W H, M, W H, M, W


RT, Isothermal amplification, Screening H, M, W Real-time RT-PCR


12/28/2020 (7/21/2020) QuantiVirus SARS-CoV-2 Multiplex Test Kit Real-time RT-PCR 4/1/2021 (3/19/2020)


12/30/2020 (7/7/2020) AMPIPROBE SARS-CoV-2 Test System 4/22/2021 (6/8/2020) 4/7/2021 (5/5/2020)


2/26/2021 Advanta Dx SARS-CoV-2 RT-PCR Assay


12/28/2020 (4/17/2020) Fosun COVID-19 RT-PCR Detection Kit 12/28/2020 (6/23/2020) GenePro SARS-CoV-2 Test 2/10/2021 (2/10/2021) Procleix SARS-CoV-2 Assay 12/28/2020 (8/21/2020) Guardant-19 5/24/2021


Aptima SARS-CoV-2 assay 5/6/2021 (12/16/2020) Aptima SARS-CoV-2/Flu assay


1/22/2021 (3/16/2020) Panther Fusion SARS-CoV-2 Assay 4/22/2021 (6/9/2020)


Illumina COVIDSeq Test 5/11/2021 (3/16/2020) COVID-19 RT-PCR Test


5/11/2021 (12/9/2020) Pixel by LabCorp COVID-19 Test Home Collection Kit


5/18/2021 (4/15/2021) Biosearch Technologies SARS-CoV-2 Real- Time and End-Point RT-PCR Test


3/3/2021


NxTAG Respiratory Pathogen Panel + SARS-CoV-2


H H


Real-time RT-PCR


Real-time RT-PCR, Pooling Real-time RT-PCR Real-time RT-PCR


H, M H H H


Real-time RT-PCR, Saliva, Home Collection H Real-time RT-PCR Real-time RT-PCR TMA


Sequencing


Real-time TMA, chemiluminescent, Multi-analyte


H H H H


TMA, chemiluminescent, Pooling, Screening H H


Real-time RT-PCR, Pooling, Screening Sequencing


Real-time RT-PCR, Home Collection, Pooling, Screening


Direct to Consumer (DTC), Real-time RT- PCR, Home Collection, Pooling, Screening


Real-Time and End-Point RT-PCR RT-PCR, Multi-analyte 3/29/2021 (10/14/2020) LumiraDx SARS-CoV-2 RNA STAR Complete RT, qSTAR amplification


H H H


H H H H


18 CLR 2021-2022 • MLO • www.clr-online.com


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