Test Manufacturer (linked) | Date of EUA Issuance (linked) | Type of Test |
SML GENETREE Co., Ltd. | 1/13/21 | rRT-PCR |
PerkinElmer | 1/12/2021 (original 3/24/2020) | rRT-PCR |
Becton, Dickinson and Company (BD) | 1/13/2021 (original 7/2/2020) | Rapid antigen Test |
Ortho Clinical Diagnostics, Inc. | 1/11/21 | Rapid Antigen Test |
Quanterix Corporation | 1/8/21 | Antigen Paramagnetic Microbead-based Immunoassay |
Centers for Disease Control and Prevention (CDC) | 1/8/21 (original 7/2/2020) | rRT-PCR |
Fluidigm Corporation | 2nd revision: 1/8/21; 1st revision: 11/5/2020 (originial 8/25/2020) | rRT-PCR |
Mesa Biotech | 1/7/2021 (original 3/23/2020) | PCR and lateral flow |
OPTI Medical Systems | 1/4/2020 (original 5/6/2020) | rRT-PCR |
Cepheid | 12/23/20 | rRT-PCR, pooled |
Quidel Corporation | 12/23/20 | molecular isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) |
Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) | 12/17/20 | RT-PCR plus isothermal amplification |
Quidel Corporation | 12/18/20 | Rapid Antigen Test |
Hologic, Inc. | 12/16/20 | multiplexed, Real-Time Transcription Mediated Amplification (RT-TMA) |
Abbott Diagnostics Scarborough, Inc. | 12/16/20 | Rapid Antigen Test |
Roche Molecular Systems, Inc. | 12/10/2020 (originial 9/15/2020) | rRT-PCR, multiplexed |
Ellume Limited | 12/15/20 | Rapid Antigen Test |
BioRad Laboratories, Inc | 12/9/2020 (original 5/1/2020) | digital droplet rRT-PCR |
Bioeksen R&D Technologies Ltd | 9/2/2020 (updated 12/9/2020) | rRT-PCR |
Laboratory Corporation of America (“LabCorp”) | 12/9/20 | direct to consumer, at home collection |
Luminostics, Inc. | 12/7/20 | Antigen |
BioFire Defense LLC | reissued 12/4/2020 (original 3/23/2020) | rRT-PCR |
Rheonix, Inc. | reissued 12/3/2020 (original 4/29/2020) | rRT-PCR |
Applied Biocode, Inc. | reissued 12/7/2020; 10/22/2020 (original 6/15/2020) | rRT-PCR |
Centers for Disease Control and Prevention (CDC) | 12/1/2020 (original on 2/4/2020) | rRT-PCR |
Agena Bioscience, Inc. | 11/30/2020 (original 10/26/2020) | rRT-PCR, MALDI-TOF |
Cepheid | 11/27/20 | rRT-PCR |
Quest Diagnostics | 11/27/2020 (original 7/15/2020) | Observed home collection |
Quest Diagnostics | 2nd revision 11/13/2020; 1st revision 9/21/2020 (original 3/17/2020) | rRT-PCR |
Lucira Health, Inc | 11/17/20 | RT-LAMP |
Xiamen Zeesan Biotech Co., Ltd. | 11/10/2020 (original 7/31/2020) | rRT-PCR |
BioMérieux SA | 11/6/2020 (original 5/6/2020) | rRT-PCR |
Euroimmun US | 11/04/2020 (original 6/8/2020) | rRT-PCR |
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | 10/31/2020 (original 9/9/2020) | rRT-PCR |
Luminex Molecular Diagnostics | 10/28/2020 (original 3/27/2020) | rRT-PCR |
Luminex Molecular Diagnostics | 10/28/2020 (original 4/3/2020) | rRT-PCR |
PrivaPath Diagnostics, Inc. | 10/28/2020 (original 5/28/2020) | Self-collection of sample |
Illumina, Inc. | 10/28/2020 (original 6/9/2020) | Next Generation Sequencing (NGS) |
Roche Molecular Systems, Inc. | 10/28/2020 (original 9/3/2020) | rRT-PCR, multiplexed |
DiaCarta, Inc. | 10/26/2020 (original 7/21/2020) | rRT-PCR |
Celltrion USA, Inc. | 10/23/20 | Antigen |
Roche Molecular Systems, Inc. | 10/15/2020 (original 3/12/2020) | rRT-PCR |
LumiraDx UK Ltd. | 10/14/20 | RT-qSTAR amplification |
Quidel Corporation | 10/2/20 | Rapid Antigen Test |
Thermo Fisher Scientific | 10/9/2020 (original 3/13/2020) | rRT-PCR |
Spectrum Solutions LLC | 10/8/2020 | saliva collection only |
Access Bio, Inc. | 10/8/2020 | Rapid Antigen Test |
GenMark Diagnostics, Inc. | 10/7/2020 | multiplex rRT-PCR, electrochemical detection |
Seasun Biomaterials, Inc. | 10/5/2020 | RT-LAMP |
BioFire Diagnostics, LLC | 10/2/2020 | nested multiplex rRT-PCR |
Clear Labs, Inc. | 9/23/2020 | rRT-PCR and NGS |
Becton, Dickinson, and Company | 9/21/2020(original 4/8/2020) | rRT-PCR |
Becton, Dickinson, and Company | 9/21/2020 (original 4/2/2020) | rRT-PCR |
ScienCell Research Laboratories | 9/21/2020 (original was 4/3/2020) | rRT-PCR |
Quadrant Biosciences, Inc. | 9/22/20 | rRT-PCR |
Vela Operations Singapore Pte. Ltd | 9/22/20 | rRT-PCR |
Cepheid | updated 9/21/2020 (original 3/20/2020) | rRT-PCR |
KimForest Enterprise Co., Ltd. | 9/21/20 | rRT-PCR |
GK Pharmaceuticals Contract Manufacturing Operations | 9/18/20 | rRT-PCR |
Abbott Diagnostics Scarborough | 9/17/2020 amended, 3/27/2020 original | LAMP |
Visby Medical, Inc. | 9/16/20 | rRT-PCR |
Hologic, Inc. | 9/15/2020 amended, 5/14/2020 original | Dual Kinetic Assay (DKA) |
Kaiser Permanente Mid-Atlantic States | 9/9/2020, original 6/13/2020 | N/A |
BilliontoOne, Inc. | 9/4/2020 | Sequencing |
Detectachem Inc | 9/1/2020 | RT-LAMP |
OPTOLANE Technologies, Inc. | 9/1/2020 | rRT-PCR |
T2 Biosystems, Ltd | 8/31/2020 | qualitative T2 magnetic resonance |
Mammoth Biosciences, Inc | 8/31/2020 | RT-LAMP |
Abbott Diagnostics Scarborough, Inc. | 8/26/2020 | Rapid Antigen Test |
LumiraDx UK Ltd. | 8/18/2020 | Antigen |
ZhuHai Sinochips Bioscience Co., Ltd | 8/17/2020 | rRT-PCR |
Biomeme, Inc. | 8/11/2020 | rRT-PCR |
LumiraDx UK Ltd. | 8/11/2020 | non-isothermal nucleic acid amplification (qSTAR) |
Vela Operations Singapore Pte Ltd. | 8/5/2020 | rRT-PCR |
Jiangsu CoWin Biotech Co., Ltd. | 7/24/2020 | rRT-PCR |
Quest Diagnostics | 7/15/2020 | Observed home collection |
Quest Diagnostics | 7/15/2020 | Observed home collection |
Kogene Biotech Co, Ltd. | 7/13/2020 | rRT-PCR |
Trax Management Services/Phoenix Dx | 7/13/2020 | rRT-PCR |
BioSewoom, Inc. | 7/9/2020 | rRT-PCR |
Enzo Life Sciences, Inc. | 7/7/2020 | rRT-PCR |
Access Bio, Inc. | 7/7/2020 | rRT-PCR |
TNS Co., Ltd. (Bio TNS) | 6/30/2020 | rRT-PCR |
The Kroger Co. | 6/30/2020 | At-home collection kit |
PreciGenome LLC | 6/25/2020 | rRT-dPCR |
Plexbio, Inc. | 6/25/2020 | rRT-PCR |
Gencurix, Inc. | 6/23/2020 | rRT-PCR |
3B Blackbio Biotech India Ltd | 6/18/2020 | rRT-PCR |
Jiangsu Bioperfectus Technologies Co., Ltd | 6/18/2020 | rRT-PCR |
RTA Laboratories Biological Products Pharmaceutical and Machinery Industry | 6/12/2020 | rRT-PCR |
Tide Laboratories, LLC | 6/10/2020 | rRT-PCR |
TBG Biotechnology Corp. | 6/10/2020 | rRT-PCR |
Cue Health Inc. | 6/10/2020 | RT-LAMP |
ChromaCode | 6/9/2020 | rRT-PCR |
Genetron Health (Beijing) Co., Ltd. | 6/5/2020 | rRT-PCR |
Gravity Diagnostics | 6/1/2020 | rRT-PCR |
dba SpectronRx | 5/22/2020 | rRT-PCR |
BioCore Co., Ltd. | 5/21/2020 | rRT-PCR |
SolGent Co., Ltd. | 5/21/2020 | rRT-PCR |
Seasun Biomaterials, Inc. | 5/21/2020 | RT-LAMP |
Quidel Corporation | 5/18/2020 | rRT-PCR |
Fulgent Therapeutics, LLC | 5/15/2020 | rRT-PCR |
GeneMatrix, Inc. | 5/14/2020 | rRT-PCR |
Applied DNA Sciences Inc. | 5/13/2020 | rRT-PCR |
1drop Inc. | 5/11/2020 | rRT-PCR |
Abbott Molecular | 5/11/2020 | rRT-PCR |
Quidel Corporation | 5/8/2020 | Antigen |
Gnomegen LLC | 5/8/2020 | rRT-PCR |
Zymo Research Corporation | 5/7/2020 | rRT-PCR |
Sherlock Biosciences, Inc | 5/6/2020 | CRISPR/RT-LAMP |
Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) | 5/5/2020 | rRT-PCR |
Sansure Biotech Inc. | 5/4/2020 | rRT-PCR |
BioFire Diagnostics, LLC | 5/1/2020 | rRT-PCR |
LabGenomics Co, Ltd | 4/29/2020 | rRT-PCR |
SEASUN Biomaterials | 4/27/2020 | rRT-PCR |
SD Biosensor, Inc | 4/23/2020 | rRT-PCR |
altona Diagnostics GmbH | 4/22/2020 | rRT-PCR |
Covance/Seegene Inc | 4/21/2020 | rRT-PCR |
Trax Management Services/Phoenix Dx | 4/20/2020 | rRT-PCR |
OSANG Healthcare | 4/18/2020 | rRT-PCR |
Fosun Pharma USA, Inc | 4/17/2020 | rRT-PCR |
GenoSensor LLC | 4/16/2020 | rRT-PCR |
Curative, Inc. | 4/16/2020 | rRT-PCR |
Maccura Biotechnology, LLC | 4/15/2020 | rRT-PCR |
Atila Biosystems, Inc | 4/10/2020 | Isothermal amplification (OMEGA), patented |
DiaCarta, Inc | 4/8/2020 | rRT-PCR |
InBios International | 4/7/2020 | rRT-PCR |
Gnomegen Diagnostics | 4/6/2020 | rRT-PCR |
Co-Diagnostics, Inc. | 4/3/2020 | rRT-PCR |
Ipsum Diagnostics, LLC | 4/1/2020 | rRT-PCR |
NeuMoDx Molecular, Inc. | 3/30/2020 | rRT-PCR |
Qiagen | 3/30/2020 | rRT-PCR |
BGI Genomics Ltd. | 3/26/2020 | rRT-PCR |
PrimerDesign Ltd. | 3/20/2020 | rRT-PCR |
DiaSorin Diagnostics | 3/19/2020 | rRT-PCR |
GenMark Diagnostics | 3/19/2020 | rRT-PCR |
Abbott Molecular | 3/18/2020 | rRT-PCR |
Quidel Corporation | 3/17/2020 | rRT-PCR |
Hologic, Inc. | 3/16/2020 | rRT-PCR |
Wadsworth Center, NYSDOH | 2/29/2020 | rRT-PCR |
LDT Developer | Date of EUA Issuance | Type of Test |
Yale School of Public Health, Department of Epidemiology of Microbial Diseases | December 16, 2020 (original 8/15/2020) | rRT-PCR |
Phosphorus Diagnostics LLC | 12/15/2020 (original 6/4/2020) | rRT-PCR |
LabCorp | 12/9/2020(original 3/16/2020) | rRT-PCR |
Quest Diagnostics Infectious Disease, Inc. | 12/4/2020 | rRT-PCR |
binx health, Inc. | reissued 12/4/2020 (original 10/20/2020) | Home collection kit |
Infinity BiologiX LLC | 9/18/20, originally 4/10/20 | rRT-PCR |
Stanford Health Care Clinical Virology Laboratory | 11/24/2020 (original 4/8/2020) | rRT-PCR |
Gravity Diagnostics, LLC | 11/23/2020 | RT-PCR |
RapidRona, Inc. | 11/23/2020 | Self-collection of sample |
Color Genomics | 11/02/2020 (original 5/18/2020) | RT-LAMP |
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard | 10/23/2020 (original 7/8/2020) | rRT-PCR |
P23 Labs, LLC. | 10/20/2020 (original 5/21/2020) | rRT-PCR |
Wren Laboratories | 10/20/2020 (original 8/3/2020) | rRT-PCR |
Genetrack BioLabs, LLC | 10/17/2020 (original 9/25/2020) | rRT-PCR/at home collection |
Clinical Enterprise, Inc. | 10/15/2020 | Home collection kit |
Viracor Eurofins Clinical Diagnostics | 10/15/2020 (original 4/6/2020) | rRT-PCR |
UCLA | 10/6/2020 | NGS |
Cuur Diagnostics | 10/2/2020 (original 8/26/2020) | rRT-PCR |
Tempus Labs, Inc. | 10/1/2020 | rRT-PCR |
Aeon Global Health | 9/30/2020 | rRT-PCR |
Alimetrix, Inc. | 9/30/2020 | rRT-PCR |
Centogene US, LLC | 9/29/2020 | rRT-PCR |
Akron Children's Hospital | 9/29/2020 | rRT-PCR |
National Jewish Health | 9/29/2020 | rRT-PCR, MALDI-TOF |
Avellino Lab USA, Inc. | 3/25/2020 | rRT-PCR |
Assurance Scientific Laboratories | 8/19/2020 (original) 5/15/2020 | rRT-PCR |
Gravity Diagnostics, LLC | 9/21/2020 (original 6/1/2020) | rRT-PCR |
Acupath Laboratories, Inc. | 9/21/2020 (original 6/29/2020) | rRT-PCR |
Boston Heart Diagnostics | 9/2/2020 (original 7/16/2020) | rRT-PCR |
Eli Lilly and Company | 9/21/2020 (original 7/27/2020) | rRT-PCR |
Ethos Laboratories | 9/21/2020 (original 8/3/2020) | At-home collection, rRT-PCR and MALDI-TOF |
Exact Sciences Laboratories | 9/21/2020 (original 5/22/2020) | rRT-PCR |
Color Genomics | 9/14/2020 amended, 8/31/2020 original | At-home collection kit |
Verily Life Sciences | 9/8/2020 | rRT-PCR, pooling |
MiraDx | 8/31/2020 | rRT-PCR |
BayCare Laboratories, LLC | 8/31/2020 | rRT-PCR |
DxTerity Diagnostics, Inc. | 8/28/2020 | rRT-PCR |
Patients Choice Laboratories, LLC | 8/28/2020 | rRT-PCR |
QDx Pathology Services | 8/25/2020 | At-home collection |
Texas Department of State Health Services, Laboratory Services Section | 8/21/2020 | rRT-PCR |
DxTerity Diagnostics, Inc. | 8/21/2020 | rRT-PCR |
Guardant Health, Inc. | 8/21/2020 | rRT-PCR |
Pro-Lab Diagnostics | 8/13/2020 | RT-LAMP |
Solaris Diagnostics | 8/10/2020 | rRT-PCR |
Alpha Genomix Laboratories | 8/10/2020 | rRT-PCR |
George Washington University Public Health Laboratory | 8/7/2020 | rRT-PCR |
Helix OpCo, LLC | 8/6/2020 | NGS |
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | 8/3/2020 | rRT-PCR |
Poplar Healthcare | 8/3/2020 | transcription mediated amplification (TMA) |
ISPM Labs, LLC dba Capstone Healthcare | 8/3/2020 | rRT-PCR |
University of California San Diego Health | 7/31/2020 | rRT-PCR |
Clinical Reference Laboratory, Inc. | 7/30/2020 | rRT-PCR |
Sandia National Laboratories | 7/27/2020 | rRT-PCR |
Access Genetics, LLC. | 7/17/2020 | rRT-PCR |
Compass Laboratory Services, LLC. | 7/13/2020 | rRT-PCR |
Boston Medical Center | 7/10/2020 | rRT-PCR |
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin | 7/9/2020 | RT-LAMP |
Gene by Gene | 7/7/2020 | rRT-PCR |
Laboratorio Clinico Toledo | 7/6/2020 | rRT-PCR |
CENTOGENE US, LLC | 7/1/2020 | rRT-PCR |
Psomagen, Inc. | 6/30/2020 | rRT-PCR |
LifeHope Labs | 6/2/2020 | rRT-PCR |
Inform Diagnostics, Inc. | 6/26/2020 | rRT-PCR |
Diagnostic Solutions Laboratory, LLC | 6/25/2020 | rRT-PCR |
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory | 6/24/2020 | rRT-PCR |
HealthQuest Esoterics | 6/23/2020 | rRT-PCR |
University of Alabama Fungal Reference Lab | 6/23/2020 | |
The Ohio State University Wexner Medical Center | 6/18/2020 | rRT-PCR |
Omnipathology Solutions Medical Corporation | 6/17/2020 | rRT-PCR |
Cormeum Laboratory Services | 6/12/20 | rRT-PCR |
Warrior Diagnostics, Inc. | 6/9/20 | rRT-PCR |
Nebraska Medicine Clinical Laboratory | 6/4/20 | rRT-PCR |
Aspirus Reference Laboratory | 6/1/20 | rRT-PCR |
CSI Laboratories | 6/1/2020 | rRT-PCR |
Exact Sciences Laboratories | 5/22/2020 | rRT-PCR |
Express Gene LLC (dba Molecular Diagnostics Laboratory) | 5/22/2020 | rRT-PCR |
Avera Institute for Human Genetics | 5/22/2020 | rRT-PCR |
OneHealth Laboratories, LLC | 5/13/2020 | rRT-PCR |
Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | 5/13/2020 | rRT-PCR |
Columbia University Laboratory of Personalized Genomic Medicine | 5/12/2020 | rRT-PCR |
Biocollections Worldwide, Inc. | 5/7/2020 | rRT-PCR |
UTMG Pathology Laboratory | 5/3/2020 | rRT-PCR |
Altru Diagnostics, Inc. | 4/30/2020 | rRT-PCR |
Biocerna | 4/28/2020 | rRT-PCR |
Nationwide Children’s Hospital | 4/27/2020 | rRT-PCR |
Ultimate Dx Laboratory | 4/24/2020 | rRT-PCR |
AIT Laboratories | 4/24/2020 | rRT-PCR |
Southwest Regional PCR Laboratory LLC. dba MicroGen DX | 4/23/2020 | rRT-PCR |
Diatherix Eurofins Laboratory | 4/22/2020 | rRT-PCR |
Mayo Clinic Laboratories, Rochester, MN | 4/20/2020 | rRT-PCR |
Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | 4/15/2020 | rRT-PCR |
CirrusDx Laboratories | 4/15/2020 | rRT-PCR |
Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital | 4/14/2020 | rRT-PCR |
Exact Sciences Laboratories | 4/14/2020 | rRT-PCR |
Integrity Laboratories | 4/13/2020 | rRT-PCR |
Pathology/Laboratory Medicine Lab of Baptist Hospital Miami | 4/13/2020 | rRT-PCR |
Orig3n, Inc. | 4/10/2020 | rRT-PCR |
Specialty Diagnostic (SDI) Laboratories | 4/10/2020 | rRT-PCR |
University of North Carolina Medical Center | 4/10/2020 | rRT-PCR |
Massachusetts General Hospital | 4/3/2020 | rRT-PCR |
Diagnostic Molecular Laboratory – Northwestern Medicine | 4/2/2020 | rRT-PCR |
Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia | 4/2/2020 | rRT-PCR |
Yale New Haven Hospital, Clinical Virology Laboratory | 3/31/2020 | rRT-PCR |