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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