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COVID-19 TEST UPDATES LumiraDx UK Ltd.


Maccura Biotechnology (USA) LLC Mesa Biotech Inc.


MobileDetect Bio Inc. NeuMoDx Molecular, Inc.


NeuMoDx Molecular, Inc. OPTI Medical Systems, Inc. PathogenDx, Inc.


PerkinElmer Genomics PerkinElmer, Inc.


PlexBio Co., Ltd. Primerdesign Ltd.


Quadrant Biosciences Inc. Quidel Corporation Quidel Corporation Quidel Corporation


Roche Molecular Systems


Roche Molecular Systems, Inc. Roche Molecular Systems, Inc.


12/28/2020 (8/11/2020) LumiraDx SARS-CoV-2 RNA STAR


12/28/2020 (4/15/2020) SARS-CoV-2 Fluorescent PCR Kit 2/3/2021 (3/23/2020) 6/17/2021 (9/1/2020)


Accula SARS-Cov-2 Test


MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit


4/23/2021 (3/25/2021) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay


1/22/2021 (3/30/2020) NeuMoDx SARS-CoV-2 Assay 4/20/2021 (5/6/2020) 4/20/2021 4/12/2021


4/1/2021 (3/24/2020)


2/3/2021 (6/25/2020) 1/5/2021 (3/20/2020)


5/6/2021 (9/22/2020) 5/25/2021 (5/18/2020) 4/21/2021 (3/17/2020)


OPTI SARS-CoV-2 RT PCR Test DetectX-Rv


PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit


PerkinElmer New Coronavirus Nucleic Acid Detection Kit


IntelliPlex SARS-CoV-2 Detection Kit


Primerdesign Ltd COVID-19 genesig Real- Time PCR assay


Clarifi COVID-19 Test Kit


Lyra Direct SARS-CoV-2 Assay Lyra SARS-CoV-2 Assay


3/25/2021 (12/23/2020) Solana SARS-CoV-2 Assay 6/17/2021 6/8/2021 (9/3/2020)


cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2)


cobas SARS-CoV-2 & Influenza A/B


12/10/2020 (9/14/2020) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System


Roche Molecular Systems, Inc. (RMS) 5/14/2021 (3/12/2020) cobas SARS-CoV-2 SEASUN BIOMATERIALS


2/9/2021 (4/27/2020)


SEASUN BIOMATERIALS, Inc. Seasun Biomaterials, Inc. Seegene, Inc.


Sherlock BioSciences, Inc. SML GENETREE Co., Ltd. SolGent Co., Ltd


T2 Biosystems, Inc.


TBG Biotechnology Corp. Thermo Fisher Scientific


Thermo Fisher Scientific


Thermo Fisher Scientific Inc. Thermo Fisher Scientific, Inc. Trax Management Services Inc. Twist Bioscience Corporation Visby Medical, Inc. Visby Medical, Inc.


Zymo Research Corporation


De Novo Authorized Test BioFire


U-TOP COVID-19 Detection Kit


RT, non-isothermal nucleic acid amplifica- tion qSTAR


Real-time RT-PCR RT and amplification RT-LAMP


Real-time RT-PCR, Multi-analyte RT-PCR, Collection Kit, Saliva Real-time RT-PCR, Screening, Pooling H H


H, M, W H, M


H, M


H, M H


RT-PCR, DNA Microarray Hybridization H Real-time RT-PCR, Home Collection


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


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


Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA)


Real-time RT-PCR, Screening


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


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


4/29/2021 (10/5/2020) AQ-TOP COVID-19 Rapid Detection Kit PLUS RT-LAMP 2/23/2021 (5/21/2020) AQ-TOP COVID-19 Rapid Detection Kit 4/15/2021 (4/21/2020) 1/14/2021 (5/6/2020)


Allplex 2019-nCoV Assay Sherlock CRISPR SARS-CoV-2 Kit 4/30/2021 (1/13/2021) Ezplex SARS-CoV-2 G Kit


12/28/2020 (5/21/2020) DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit


12/28/2020 (8/31/2020) T2SARS-CoV-2 Panel


1/6/2021 (6/10/2020) 4/9/2021


ExProbe SARS-CoV-2 Testing Kit


Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit


2/10/2021 (2/10/2021) TaqPath COVID-19, FluA, FluB Combo Kit 5/25/2021 (5/25/2021) TaqPath COVID-19 Pooling Kit 2/23/2021 (3/13/2020) TaqPath COVID-19 Combo Kit 4/7/2021 (7/13/2020)


PhoenixDx SARS-CoV-2 Multiplex


3/23/2021 (3/23/2021) SARS-CoV-2 NGS Assay 2/8/2021 (2/8/2021)


RT-LAMP


Real-time RT-PCR RT-LAMP, CRISPR


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


H H


H H


H H H


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


H, M, H-Pooling H H H H H H H


RT, amplification, T2 Magnetic resonance RT, amplification, T2 Magnetic resonance


Real-time RT-PCR Real-time RT-PCR


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


Real-time RT-PCR, Home Collection Real-time RT-PCR Sequencing


12/28/2020 (9/16/2020) Visby Medical COVID-19 12/30/2020 (5/7/2020) Quick SARS-CoV-2rRT-PCR Kit


3/17/2021 De Novo Authorized


Source: U.S. Food and Drug Administration CLR 2021-2022 • MLO • www.clr-online.com 19 Respiratory 2.1 (RP2.1) Panel


Visby Medical COVID-19 Point of Care Test RT-PCR RT-PCR


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


H H


H H H H H


H, M, W H, M H


H, M


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