Friday, April 3, 2020

2-Day Online Rapid Microbiological Methods Master Class - July 15-16, 2020

Last month we held a very exciting online training program for rapid methods. To accommodate additional requests to repeat the training, the next online 2-Day Rapid Microbiological Methods Master Class will be held on July 15-16, 2020, from 1000 - 1430 EDT. This will be a live event where you will learn about the current regulatory policies for validation and submissions, the scientific principles for commercially-available rapid technologies, a comprehensive,step-by-step guide for validation including the use of statistical models, case studies on rapid sterility testing for ATMPs (cell therapy) and real-time environmental monitoring, and how to develop a financial justification when purchasing a RMM system. For the complete agenda and information on how to register, please visit http://rapidmicromethods.com/events/masterclass-july2020.php.

Tuesday, March 24, 2020

Overview of Current COVID-19 Diagnostic Devices with FDA Emergency Use Authorization

As of April 26, 2021, there are 343 in vitro diagnostic EUAs (241 molecular/collection, 23 antigen, 76 serology, 3 COVID-19 management IVD) and 85 validated serology or serum / plasma / whole blood tests that have not received an EUA. 

Please bookmark this page as I will continually update this information as additional EUA's are issued and new commercial diagnostic and serology kits are validated. All information provided in this blog are obtained from FDA's In Vitro Diagnostic EUA and FAQs on Testing for SARS-CoV-2 pages. 

In vitro (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:

Diagnostic Tests - Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.

Serology/Antibody Tests - Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection.

Tests for Management of COVID-19 Patients - Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.

Numerous COVID-19 in-vitro diagnostic devices have been submitted to FDA for Emergency Use Authorizations (EUA). The following table provides an up-to-date summary of all FDA EUA's. NOTE: the table should be viewed in landscape mode on smaller handheld devices.

There are also a number of SARS-CoV-2 diagnostic and serology tests that are in development or that have been distributed while manufacturers prepare an EUA submission for a test whose performance characteristics have already been validated. Laboratories are also offering serology tests. Current lists of diagnostic and serology tests that fit into these categories are provided after the EUA table.

For more information on serology test performance, including sensitivity (true positive rate) and specificity (true negative rate), visit FDA's EUA Authorized Serology Test Performance page.

Date of EUA Original Issue
Entity
Letter of Authorization
Attributes3
Authorized Settings1
Authorization Documents2

04/20/2021
PathogenDx, Inc.
RT-PCR, DNA Microarray Hybridization
H
04/19/2021
Inova Diagnostics, Inc.
IgG, CLIA, Semi-quantitative
H, M
04/19/2021
Southern California Permanente Medical Group
Real-Time RT-PCR, Saliva, Home Collection
H
04/16/2021
Synergy Diagnostic Laboratory, Inc., DBA SynergyDx
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening
H
04/16/2021
Celltrion USA, Inc.
Lateral Flow, Visual Read, Serial Screening
H, M, W
04/16/2021
Synergy Diagnostic Laboratory, Inc., DBA SynergyDx
Real-time RT-PCR, Home Collection, Screening
H
04/15/2021
LGC, Biosearch Technologies
Real-Time and End-Point RT-PCR
H
04/14/2021
Color Health, Inc.
RT, LAMP, Home Collection, Screening
H
04/13/2021
Qorvo Biotechnologies, LLC.
Bulk Acoustic Wave (BAW) Biosensor, Instrument Read
H, M
04/13/2021
Clinical Enterprise, Inc.
Real-time RT-PCR, Screening
H
04/13/2021
Clinical Enterprise, Inc.
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening
H
04/12/2021
PerkinElmer Genomics
Real-time RT-PCR, Home Collection
H
04/09/2021
Lucira Health, Inc.
RT, LAMP, Over the Counter (OTC) Home Testing, Screening
Home, H, M, W
04/09/2021
Thermo Fisher Scientific
Real-time RT-PCR
H
04/09/2021
Yale School of Public Health, Department of Epidemiology of Microbial Diseases
Home Collection Kit, Saliva, Screening
H
04/05/2021
Symbiotica, Inc.
ELISA, Home Collection, Fingerstick Dried Blood Spot
Home, H
03/31/2021
Abbott Diagnostics Scarborough, Inc.
Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening
Home, H, M, W
03/31/2021
Abbott Diagnostics Scarborough, Inc.
Lateral Flow, Visual Read, Non-prescription Testing, Serial Screening
H, M, W
03/31/2021
Abbott Diagnostics Scarborough, Inc.
Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening
Home, H, M, W
03/31/2021
Quidel Corporation
Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening
Home, H, M, W
03/26/2021
DiaSorin, Inc.
CLIA
H, M
03/25/2021
NeuMoDx Molecular, Inc.
Real-time RT-PCR, Multi-analyte
H, M
03/25/2021
STS Lab Holdco (a subsidiary of Amazon.com Services LLC)
Real-time RT-PCR, Home Collection, Screening
H
03/24/2021
Becton, Dickinson and Company (BD)
Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte
H, M, W
03/23/2021
Twist Bioscience Corporation
Sequencing
H
03/23/2021
Siemens Healthcare Diagnostics Inc.
IgG, CLIA, Semi-quantitative
H, M
03/22/2021
Beckman Coulter, Inc.
IgG, CLIA, Semi-quantitative
H, M
03/19/2021
Color Health, Inc.
Home Collection Kit, Direct to Consumer (DTC), Screening
N/A
03/19/2021
Color Health, Inc.
Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening
H
03/09/2021
GetMyDNA
Home Collection Kit, Direct to Consumer (DTC), Screening
N/A
03/05/2021
Cue Health Inc.
RT, Isothermal amplification Over the Counter (OTC) Home Testing, Screening
Home, H, M, W
03/05/2021
Adaptive Biotechnologies Corporation
T-cell receptor beta (TCR β), Sequencing
H
03/05/2021
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard
Real-time RT-PCR, Home Collection
H
03/04/2021
Abbott Molecular Inc.
Real-time RT-PCR, Multi-analyte
H, M
03/03/2021
Luminex Molecular Diagnostics, Inc.
RT-PCR, Multi-analyte
H
03/01/2021
Abbott Laboratories Inc.
IgG, CMIA, Semi-quantitative
H, M
03/01/2021
Quidel Corporation
Lateral Flow, Visual Read, Prescription Home Testing
Home, H, W, W
02/26/2021
Viracor Eurofins Clinical Diagnostics
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening
H
02/24/2021
University of Illinois Office of the Vice President for Economic Development and Innovation
Real-time RT-PCR, Saliva
H
02/13/2021
Gravity Diagnostics, LLC
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening
H
02/13/2021
Assurance Scientific Laboratories
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening
H
02/13/2021
Everlywell, Inc.
Home Collection Kit, Direct to Consumer (DTC), Screening
N/A
02/11/2021
Bio-Rad Laboratories, Inc.
Real-time RT-PCR, Multi-analyte
H
02/10/2021
Immunodiagnostic Systems Ltd.
IgG, CLIA
H, M
02/10/2021
Becton, Dickinson and Company (BD)
Real-time RT-PCR, Multi-analyte
H, M
02/10/2021
Thermo Fisher Scientific
Real-time RT-PCR, Multi-analyte
H
02/10/2021
Grifols Diagnostic Solutions Inc.
TMA
H
02/08/2021
Visby Medical, Inc.
RT-PCR
H, M, W
02/04/2021
Princeton BioMeditech Corp.
Lateral Flow, Visual Read, Multi-analyte
H, M, W
02/04/2021
Clinomics USA Inc.
Real-time RT-PCR
H
01/22/2021
Ambry Genetics Laboratory
Real-time RT-PCR, Home Collection, Saliva
H
01/19/2021
Hospital of the University of Pennsylvania
Real-time RT-PCR
H
01/19/2021
INNO Diagnostics Reference Laboratory, Ponce Medical School
Real-time RT-PCR
H
01/15/2021
United Biomedical, Inc.
IgG, ELISA
H
01/15/2021
Bio-Rad Laboratories, Inc.
Real-time RT-PCR
H
01/14/2021
SML GENETREE Co., Ltd.
Real-time RT-PCR, Pooling
H
01/11/2021
Phadia AB
IgG, Fluoro-enzyme Immuno-assay, Semi-quantitative
H, M
01/11/2021
ADVAITE, Inc.
IgG, Lateral Flow, Fingerstick Whole Blood
H, M, W
01/11/2021
Ortho Clinical Diagnostics, Inc.
Chemilumin-escence Immuno-assay, Instrument Read
H, M
01/08/2021
Siemens Healthcare Diagnostics Inc.
IgG, CLIA, Semi-quantitative
H, M, W
01/08/2021
Siemens Healthcare Diagnostics Inc.
IgG, CLIA, Semi-quantitative
H, M, W
01/05/2021
Quanterix Corporation
Para-magnetic Microbead-based Immuno-assay
H, M
12/31/2020
Nirmidas Biotech, Inc.
IgM and IgG, lateral flow
H, M, W
12/23/2020
Cepheid
Real-time RT-PCR, Pooling
H, M, W
12/23/2020
Quanterix Corporation
IgG, Para-magnetic Microbead-based Sandwich ELISA, Semi-quantitative
H, M
12/23/2020
Quidel Corporation
Isothermal Reverse Tran-scriptase – Helicase-Dependent Amplification (RT-HDA)
H, M
12/18/2020
Quidel Corporation
Lateral Flow, Visual Read
H, M, W
12/18/2020
Siemens Healthcare Diagnostics Inc.
One-step Direct Chemilumin-escent Immuno-assay
H, M
12/17/2020
Materials and Machines Corporation of America (DBA MatmaCorp, Inc.)
RT-PCR and isothermal nucleic acid amplification
H
12/17/2020
Hologic, Inc.
Real-time TMA, Chemilumin-escent, Multi-analyte
H
12/16/2020
Abbott Diagnostics Scarborough, Inc.
Lateral Flow, Visual Read, Prescription Home Testing
12/15/2020
ACON Laboratories, Inc.
IgM and IgG, Lateral Flow
H, M
12/15/2020
Ellume Limited
Lateral Flow, Fluore-scence, Instrument Read, Over the Counter
12/15/2020
RCA Laboratory Services LLC dba GENETWORx
Real-time RT-PCR, Home Collection
H
12/11/2020
ResearchDx, Inc., DBA Pacific Diagnostics
TMA, Chemilumin-escent, Home Collection
H
12/09/2020
Laboratory Corporation of America (LabCorp)
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening
H
12/07/2020
Luminostics, Inc.
Lateral flow immuno-luminescent assay, instrument read
H, M, W
12/04/2020
Quest Diagnostics Infectious Disease, Inc.
Real-time RT-PCR, Multi-analyte, Home Collection
H
11/27/2020
Cepheid
Real-time RT-PCR
H, M
11/25/2020
Roche Diagnostics, Inc.
Total Antibody, ECLIA, Semi-quantitative
H, M
11/24/2020
Kantaro Biosciences, LLC
IgG, ELISA, Semi-quantitative
H
11/23/2020
Innovita (Tangshan) Biological Technology Co., Ltd.
IgM and IgG, Lateral Flow
H, M
11/23/2020
RapidRona, Inc.
Home Collection Kit
N/A
11/23/2020
Gravity Diagnostics, LLC
Real-time RT-PCR, Home Collection, Screening, Saliva
H
11/17/2020
Lucira Health, Inc.
Prescription Home Testing
W
11/06/2020
GenScript USA Inc.
Total Neutralizing Antibodies, Blocking ELISA
H
10/28/2020
Quansys Biosciences, Inc.
IgG, CLIA
H
10/28/2020
DNA Genotek Inc.
Saliva Collection Device
N/A
10/26/2020
Agena Bioscience, Inc.
RT-PCR, chip array and MALDI-TOF Mass Spec.
H
10/23/2020
Celltrion USA, Inc.
Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA)
H, M
10/20/2020
binx health, Inc.
Home Collection Kit
N/A
10/15/2020
Clinical Enterprise, Inc.
Home Collection Kit
N/A
10/14/2020
DNA Genotek Inc.
Saliva Collection Device
N/A
10/14/2020
LumiraDx UK Ltd.
RT, qSTAR amplification
H
10/09/2020
Abbott Laboratories Inc.
IgM, CMIA
H, M
10/08/2020
Access Bio, Inc.
Lateral Flow, Visual Read
H, M, W
10/08/2020
Beckman Coulter, Inc.
IgM, CLIA
H, M
10/08/2020
Spectrum Solutions LLC
Saliva Collection Device
N/A
10/07/2020
GenMark Diagnostics, Inc.
RT-PCR and electro-chemical detection, Multi-analyte
H, M
10/06/2020
University of California, Los Angeles (UCLA)
RT-PCR and Sequencing
H
10/06/2020
ZEUS Scientific, Inc.
IgG, ELISA
H, M
10/05/2020
Season Biomaterials, Inc.
RT-LAMP
H
10/02/2020
Quidel Corporation
Lateral Flow, Fluore-scence, Instrument Read, Multi-Analyte
H, M, W
10/02/2020
Thermo Fisher Scientific
Total Antibody, ELISA
H, M
10/02/2020
BioFire Diagnostics, LLC
RT, Nested multiplex PCR, Multi-Analyte
H, M, W
10/01/2020
Beckman Coulter, Inc.
One-step immuno-enzymatic ("sandwich") assay, IL-6
H, M
10/01/2020
UMass Memorial Medical Center
Real-time RT-PCR
H
10/01/2020
Tempus Labs, Inc.
Real-time RT-PCR
H
09/30/2020
Aeon Global Health
Real-time RT-PCR
H
09/30/2020
Alimetrix, Inc.
RT-PCR, Microarray Hybridization
H
09/29/2020
CENTOGENE US, LLC
Real-time RT-PCR, Screening
H
09/29/2020
Akron Children’s Hospital
Real-time RT-PCR
H
09/29/2020
National Jewish Health
RT-PCR and MALDI-TOF Mass Spec.
H
09/29/2020
DiaSorin, Inc.
IgM, Indirect CLIA
H, M
09/29/2020
NanoEntek America, Inc.
Total Antibody, FIA
H, M
09/29/2020
Nirmidas Biotech, Inc.
IgM and IgG, Lateral Flow
H, M
09/25/2020
Genetrack Biolabs, Inc.
Real-time RT-PCR
H
09/25/2020
Quotient Suisse SA
Total Antibody, photometric immuno-assay
H
09/24/2020
Cepheid
Real-time RT-PCR, Multi-analyte
H, M, W
09/23/2020
Jiangsu Well Biotech Co., Ltd.
IgM and IgG, Lateral Flow
H, M
09/23/2020
Clear Labs, Inc.
RT-PCR and Sequencing
H
09/22/2020
Quadrant Biosciences Inc.
Real-time RT-PCR, Saliva
H
09/22/2020
Vela Operations Singapore Pte. Ltd.
Real-time RT-PCR
H
09/21/2020
KimForest Enterprise Co., Ltd.
Real-time RT-PCR
H
09/18/2020
GK Pharmaceuticals Contract Manufacturing Operations
Real-time RT-PCR
H
09/16/2020
Visby Medical, Inc.
RT-PCR
H, M
09/14/2020
Roche Molecular Systems, Inc.
Real-time RT-PCR, Multi-analyte
H, M, W
09/14/2020
Shenzhen New Industries Biomedical Engineering Co., Ltd.
IgM and IgG, CLIA
H, M
09/09/2020
BioCheck, Inc.
IgM, CLIA
H, M
09/09/2020
BioCheck, Inc.
IgG, CLIA
H, M
09/09/2020
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Real-time RT-PCR
H
09/08/2020
Verily Life Sciences
Real-time RT-PCR, Pooling
H
09/04/2020
BillionToOne, Inc.
Sequencing
H
09/03/2020
Sugentech, Inc.
IgG, Lateral Flow
H, M
09/03/2020
Roche Molecular Systems, Inc.
Real-time RT-PCR, Multi-analyte
H, M
09/02/2020
Real-time RT-PCR
Molecular
H
09/01/2020
Detectachem Inc.
RT-LAMP
H
09/01/2020
OPTOLANE Technologies, Inc.
Real-time RT-PCR
H
08/31/2020
TBG Biotechnology Corp.
IgM and IgG, Lateral Flow
H, M
08/31/2020
University of Arizona Genetics Core for Clinical Services
Total Antibody, ELISA
H
08/31/2020
T2 Biosystems, Inc.
RT, amplification, T2 Magnetic resonance
H
08/31/2020
MiraDx
Real-time RT-PCR
H
08/31/2020
Mammoth Biosciences, Inc.
RT-LAMP, CRISPR
H
08/31/2020
BayCare Laboratories, LLC
Real-time RT-PCR, Pooling
H
08/31/2020
Color Genomics, Inc.
Home Collection Kit
08/28/2020
Patients Choice Laboratories, LLC
Real-time RT-PCR
H
08/28/2020
DxTerity Diagnostics, Inc.
Real-time RT-PCR, Home Collection, Screening, Saliva
H
08/26/2020
Cuur Diagnostics
Real-time RT-PCR
H
08/26/2020
Abbott Diagnostics Scarborough, Inc.
Antigen Lateral Flow, Visual Read
H, M, W
08/25/2020
Biocan Diagnostics Inc.
IgM and IgG, Lateral Flow
H, M
08/25/2020
Fluidigm Corporation
Real-time RT-PCR, Saliva
H
08/25/2020
QDx Pathology Services
Real-time RT-PCR, Home Collection
H
08/21/2020
Guardant Health, Inc.
Sequencing
H
08/21/2020
DxTerity Diagnostics, Inc.
Real-time RT-PCR, Saliva
H
08/21/2020
Texas Department of State Health Services, Laboratory Services Section
Real-time RT-PCR
H
08/18/2020
LumiraDx UK Ltd.
Antigen Microfluidic Immuno-fluorescence Assay, Instrument Read
H, M, W
08/17/2020
BioCheck, Inc.
IgM and IgG, CLIA
H, M
08/17/2020
Diazyme Laboratories, Inc.
IgM, CLIA
H, M
08/17/2020
ZhuHai Sinochips Bioscience Co., Ltd.
Real-time RT-PCR
H
08/15/2020
Yale School of Public Health, Department of Epidemiology of Microbial Diseases
Real-time RT-PCR, Saliva
H
08/13/2020
Pro-Lab Diagnostics
RT, Isothermal amplification
H
08/11/2020
Biomeme, Inc.
Real-time RT-PCR
H
08/11/2020
LumiraDx UK Ltd.
RT, non-isothermal nucleic acid amplification qSTAR
H
08/10/2020
Solaris Diagnostics
Real-time RT-PCR
H
08/10/2020
Alpha Genomix Laboratories
Real-time RT-PCR
H
08/07/2020
George Washington University Public Health Laboratory
Real-time RT-PCR
H
08/06/2020
bioMérieux SA
IgM, ELFA
H, M
08/06/2020
bioMérieux SA
IgG, ELFA
H, M
08/06/2020
Helix OpCo LLC (dba Helix)
Sequencing
H
08/05/2020
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Total Antibody, ELISA
H
08/05/2020
Vela Operations Singapore Pte Ltd.
Real-time RT-PCR
H
08/03/2020
ISPM Labs, LLC dba Capstone Healthcare
Real-time RT-PCR
H
08/03/2020
Wren Laboratories LLC
Real-time RT-PCR
H
08/03/2020
Ethos Laboratories
RT-PCR and MALDI-TOF Mass Spec.
H
08/03/2020
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
Real-time RT-PCR
H
08/03/2020
Poplar Healthcare
TMA, chemiluminescent, Pooling
H
07/31/2020
Siemens Healthcare Diagnostics Inc.
IgG, Semi-quantitative
H, M
07/31/2020
Siemens Healthcare Diagnostics Inc.
IgG, Semi-quantitative
H, M
07/31/2020
Xiamen Zeesan Biotech Co., Ltd.
Real-time RT-PCR
H
07/31/2020
University of California San Diego Health
Real-time RT-PCR, Pooling
H
07/30/2020
Clinical Reference Laboratory, Inc.
Real-time RT-PCR, Home Collection, Saliva
H
07/27/2020
Eli Lilly and Company
Real-time RT-PCR
H
07/27/2020
Sandia National Laboratories
Real-time RT-PCR
H
07/24/2020
Xiamen Biotime Biotechnology Co., Ltd.
IgM and IgG, Lateral Flow
H, M
07/24/2020
Access Bio, Inc.
IgM and IgG, Lateral Flow
H, M
07/24/2020
Jiangsu CoWin Biotech Co., Ltd.
Real-time RT-PCR
H
07/23/2020
Helix OpCo LLC (dba Helix)
Real-time RT-PCR
H
07/21/2020
DiaCarta, Inc.
Real-time RT-PCR
H
07/17/2020
Megna Health, Inc.
IgM and IgG, Lateral Flow
H, M
07/17/2020
Access Genetics, LLC
Real-time RT-PCR
H
07/16/2020
Boston Heart Diagnostics
Real-time RT-PCR
H
07/16/2020
Luminex Corporation
IgG, FMIA
H
07/15/2020
Quest Diagnostics Infectious Disease, Inc.
Real-time RT-PCR, Home Collection
H
07/15/2020
Quest Diagnostics Infectious Disease, Inc.
Real-time RT-PCR, Home Collection
H
07/15/2020
Quest Diagnostics Infectious Disease, Inc.
TMA, chemiluminescent, Home Collection
H
07/13/2020
Salofa Oy
IgM and IgG, Lateral Flow
H, M
07/13/2020
KogeneBiotech Co., Ltd.
Real-time RT-PCR
H
07/13/2020
Trax Management Services Inc.
Real-time RT-PCR
H
07/13/2020
Compass Laboratory Services, LLC
Real-time RT-PCR, Home Collection
H
07/10/2020
Boston Medical Center
Real-time RT-PCR
H
07/10/2020
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
Total Antibody, Lateral Flow
H, M
07/09/2020
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin
RT-LAMP
H
07/09/2020
BioSewoom, Inc.
Real-time RT-PCR
H
07/08/2020
Diazyme Laboratories, Inc.
IgG, CLIA
H, M
07/08/2020
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard
Real-time RT-PCR
H
07/07/2020
Enzo Life Sciences, Inc.
Real-time RT-PCR
H
07/07/2020
Access Bio, Inc.
Real-time RT-PCR
H
07/07/2020
Gene By Gene
Real-time RT-PCR
H
07/06/2020
Assure Tech. (Hangzhou Co., Ltd)
IgM and IgG, Lateral Flow
H, M
07/06/2020
Laboratorio Clinico Toledo
Real-time RT-PCR
H
07/02/2020
Becton, Dickinson and Company (BD)
Antigen Chromato-graphic Digital Immuno-assay, Instrument Read
H, M, W
07/02/2020
Centers for Disease Control and Prevention (CDC)
Real-time RT-PCR, Multi-analyte
H
07/01/2020
CENTOGENE US, LLC
Real-time RT-PCR
H
06/30/2020
InBios International, Inc.
IgM, ELISA
H
06/30/2020
Psomagen, Inc.
Real-time RT-PCR
H
06/30/2020
TNS Co., Ltd (Bio TNS)
RT-PCR
H
06/30/2020
The Kroger Co.
Home Collection Kit
06/29/2020
LifeHope Labs
Real-time RT-PCR
H
06/29/2020
Acupath Laboratories, Inc.
Real-time RT-PCR
H
06/26/2020
Beckman Coulter, Inc.
IgG , CLIA
H, M
06/26/2020
Inform Diagnostics, Inc.
Real-time RT-PCR
H
06/25/2020
Diagnostic Solutions Laboratory, LLC
Real-time RT-PCR
H
06/25/2020
PreciGenome LLC
RT-digital droplet PCR
H
06/25/2020
PlexBio Co., Ltd.
RT-PCR
H
06/24/2020
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory
Real-time RT-PCR
H
06/23/2020
HealthQuest Esoterics
Real-time RT-PCR
H
06/23/2020
University of Alabama at Birmingham Fungal Reference Lab
Real-time RT-PCR
H
06/23/2020
Gencurix, Inc.
Real-time RT-PCR
H
06/23/2020
Babson Diagnostics, Inc.
IgG , CLIA
H
06/19/2020
Hangzhou Laihe Biotech Co., Ltd.
IgM and IgG Lateral Flow
H, M
06/18/2020
Biohit Healthcare (Hefei) Co. Ltd.
IgM and IgG Lateral Flow
H, M
06/18/2020
Jiangsu Bioperfectus Technologies Co., Ltd.
Real-time RT-PCR
H
06/18/2020
3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.
Real-time RT-PCR
H
06/17/2020
The Ohio State University Wexner Medical Center
Real-time RT-PCR
H
06/17/2020
Omnipath-ology Solutions Medical Corporation
Real-time RT-PCR
H
06/15/2020
Applied BioCode, Inc.
RT-PCR
H
06/15/2020
Emory Medical Laboratories
Serology IgG
H
06/13/2020
Kaiser Permanente Mid-Atlantic States
Real-time RT-PCR, Home Collection, Screening
H
06/12/2020
RTA Laboratories Biological Products Pharma-ceutical and Machinery Industry
Real-time RT-PCR
H
06/10/2020
InBios International, Inc.
Serology IgG
H
06/10/2020
Tide Laboratories, LLC
Real-time RT-PCR
H
06/10/2020
TBG Biotechnology Corp.
Real-time RT-PCR
H
06/10/2020
Cue Health Inc.
RT, Isothermal amplification
H, W, M
06/09/2020
Illumina, Inc.
Sequencing
H
06/09/2020
ChromaCode Inc.
Real-time RT-PCR
H
06/08/2020
Siemens Healthcare Diagnostics Inc.
Total Antibody
H, M
06/08/2020
Euroimmun US Inc.
Real-time RT-PCR
H
06/05/2020
Genetron Health (Beijing) Co., Ltd.
Real-time RT-PCR
H
06/04/2020
Vibrant America Clinical Labs
Serology IgM and IgG
H
06/04/2020
Phosphorus Diagnostics LLC
Real-time RT-PCR, Home Collection, Saliva
H
06/04/2020
Hangzhou Biotest Biotech Co., Ltd.
Serology IgM and IgG
H
06/02/2020
Roche Diagnostics
Immuno-assay IL-6
H, M
06/01/2020
Gravity Diagnostics, LLC
Real-time RT-PCR, Home Collection
H
05/29/2020
Healgen Scientific LLC
Serology IgM and IgG
H, M
05/29/2020
Siemens Healthcare Diagnostics Inc.
Total Antibody
H, M
05/29/2020
Siemens Healthcare Diagnostics Inc.
Total Antibody
H, M
05/28/2020
PrivaPath Diagnostics, Inc.
TMA, chemiluminescent, Home Collection
H
05/22/2020
dba SpectronRx
Real-time RT-PCR
H
05/22/2020
Exact Sciences Laboratories
Real-time RT-PCR, Home Collection
H
05/21/2020
BioCore Co., Ltd.
Real-time RT-PCR
H
05/21/2020
SolGent Co., Ltd.
Real-time RT-PCR
H
05/21/2020
Seasun Biomaterials, Inc.
RT-LAMP
H
05/21/2020
P23 Labs, LLC.
Real-time RT-PCR, Home Collection, Saliva
H
05/18/2020
Quidel Corporation
Real-time RT-PCR