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
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44
