FDA COMBATING COVID-19 WITH MEDICAL DEVICES
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Updated August 25, 2020
FDA COMBATING COVID-19 WITH MEDICAL DEVICES
Since the beginning of the COVID-19 pandemic, FDA has been working to facilitate the development and availability of
medical products and equipment for use by patients, physicians and healthcare systems as expeditiously and safely as
possible. All of FDA’s latest actions around COVID-19 are available on our website.
During public health emergencies, FDA can use emergency authorities, including Emergency Use Authorizations (EUAs), to
help make medical products available as quickly as possible by allowing unapproved medical products to reach patients in
need when there are no adequate, FDA-approved and available alternatives. These products may include tests to help
diagnose diseases, critical medical devices needed by patients or healthcare personnel in the context of a public health
crisis, and drugs to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or
conditions.
During this pandemic, there have been a number of supply issues that have made it challenging to obtain access to
diagnostic tests and test supplies (like swabs), and medical equipment. We are updating FAQs on our webpage regularly
to provide information on diagnostic testing, including alternative test supplies and ways to conduct testing when
necessary. If test developers or labs are having any issues developing or running tests, and for difficulties obtaining
medical devices such as personal protective equipment (PPE) and other medical equipment shortages, please see
Contacts for Medical Devices During the COVID-19 Pandemic.
Testing is one of the pillars of our nation’s response to COVID-19 and the FDA continues to take actions to help make
these critical products available, including by issuing EUAs. During this pandemic, FDA has issued EUAs for different types
of COVID-19 tests. One type are polymerase chain reaction (PCR) tests, a molecular diagnostic testing technique that
detects the genetic material from the virus and can help diagnose an active COVID-19 infection. Another type of
authorized COVID-19 tests are antigen diagnostic tests, designed for the rapid detection of proteins from the virus that
causes COVID-19. A third type are serological tests which can help identify individuals who have developed an adaptive
immune response to the virus, indicating recent or prior infection, by detecting antibodies to SARS-CoV-2 in human blood
specimens (serological, or antibody, tests should not be used to diagnose active infection).
The molecular diagnostic tests are generally authorized for qualitative detection of nucleic acid from SARS-CoV-2 in
specific upper and lower respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. The
specific specimen types for each test can be found in the authorization letter. Some molecular diagnostic tests may
require a highly trained operator to manually perform the test (e.g., perform an RNA extraction step usually using specific
extraction platforms and kits), while other tests are automated and require only limited training to perform. Typically,
manually performed tests are authorized for use by laboratories certified to perform high-complexity tests, while
automated tests are authorized for use by laboratories certified to perform moderate complexity tests and/or at the
point-of-care by facilities operating under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.
Antigen tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal
cavity using swabs. One of the main advantages of an antigen test is the speed of the test, which can provide results in
minutes. However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test.
Antigen tests are very specific for the virus but are not as sensitive as molecular PCR tests. This means that positive results
Newest authorizations are in bold 1Updated August 25, 2020
from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out
infection.
The serological (antibody) tests are generally authorized for the qualitative detection of antibodies to SARS-CoV-2 in
blood, serum, and/or plasma, and are intended for use as an aid in identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or prior infection. The specific specimen types for each test can be found in
the authorization letter. These tests should not be used to diagnose active infection.
Beyond tests that diagnose or detect SARS-CoV-2 virus or detect 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.
In addition to COVID-19 tests, the FDA has issued EUAs for other devices, such as ventilators, respirators, face shields, and
decontamination systems to treat COVID-19 patients and to protect healthcare workers. The list below includes the
device EUAs that FDA has issued to date to diagnose, treat and prevent the spread of COVID-19.
Additional Resources
• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) Immediately in Effect
Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
• Insight into FDA's Revised Policy on Antibody Tests: Prioritizing Access and Accuracy
• FAQs on Testing for SARS-CoV-2
• EUA Authorized Serology Test Performance
• Hospital Beds, Stretchers, and Mattresses During the COVID-19 Public Health Emergency
• Emergency Use Authorization--Archived Information
Contents
• Blood Purification Devices EUAs
• Continuous Renal Replacement Therapy and hemodialysis Devices EUAs
• In Vitro Diagnostics EUAs
o Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
o Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories
Certified Under CLIA To Perform High Complexity Tests
o Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
o Individual EUAs for Serology Tests for SARS-CoV-2
o Individual EUAs for IVDs for Management of COVID-19 Patients
• Decontamination Systems for Personal Protective Equipment EUAs
• Infusion Pump EUAs
• Personal Protective Equipment EUAs
o N95 and Other Respirators EUAs (including EUAs for NIOSH-approved N95s and imported respirators)
o Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured
in China
o Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
o Face Shields and Other Barrier EUAs
• Remote or Wearable Patient Monitoring Devices EUAs
• Respiratory Assist Devices EUAs
• Ventilators and Ventilator Accessories EUAs
• Other Medical Device EUAs
Newest authorizations are in bold 2Updated August 25, 2020
BLOOD PURIFICATION DEVICES
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Terumo BCT Inc. and Spectra Optia Apheresis System • Blood purification system to treat patients 18 years
Market Therapeutics AG with the Depuro D2000 older with confirmed COVID-19 diagnosis admitted
Adsorption Cartridge to the intensive care unite with confirmed or
4/09/2020 imminent respiratory failure
CytoSorbents, Inc. CytoSorb Device • Blood purification system to treat patients 18 years
(Extracorporeal Blood older with confirmed COVID-19 diagnosis admitted
Purification (EBP) Device) to the intensive care unit with confirmed or
4/10/2020 imminent respiratory failure
ExThera Medical Seraph 100 Microbind Affinity • Blood purification system to treat patients 18 years
Corporation Blood Filter Device older with confirmed COVID-19 diagnosis admitted
to the intensive care unit with confirmed or
4/17/2020 imminent respiratory failure
Baxter Healthcare oXiris Set device • The oXiris Set device is an extracorporeal blood
Corporation purification device used to treat patients 18 years
of age or older with confirmed COVID-19 admitted
to the intensive care unit (ICU) with confirmed or
imminent respiratory failure in need of blood
purification, including use in continuous renal
replacement therapy, to reduce pro-inflammatory
4/22/2020 cytokines levels
C ONTINIOUS RENAL REPLACEMENT THERAPY AND HEMODIALYSIS DEVICES
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
B axter Health Corporation Prismaflex HF20 Set • C ontinuous renal replacement therapy (CRRT) to
treat low weight (8 kilograms (kg) (18 pounds (lbs))
to 20 kg (44 lbs)) and low blood volume patients or
pa tients2 who have acute renal failure, fluid
overload, or both, and who cannot tolerate a larger
extracorporeal circuit volume in an acute care
8/10/2020 environment
Baxter Healthcare Prismaflex ST Set • Continuous renal replacement therapy (CCRT) to
Corporation treat patients with acute renal failure, fluid
overload, or both in an acute care environment
5/20/2020 during COVID-19
Fresenius Medical multiFiltrate PRO System and • Provides continuous renal replacement therapy
multiBic/multiPlus Solutions (CRRT) to treat patients in an acute care
environment during the Coronavirus Disease 2019
4/30/2020 (COVID-19) pandemic.
Newest authorizations are in bold 3Updated August 25, 2020
IN VITRO DIAGNOSTICS – MOLECULAR
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.
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Center for Disease Control CDC 2019-nCoV Real-Time RT- • Developed by CDC and initially distributed to public
and Prevention PCR Diagnostic Panel health labs across the country
2/4/2020 • Testing is limited to high complexity labs
Wadsworth – New York New York SARS-CoV-2 Real-time • Developed by Wadsworth based on CDC’s published
State Public Health Reverse Transcriptase (RT)-PCR protocol
Diagnostic Panel • Run in qualified labs across New York State
2/29/2020 • Testing is limited to high complexity labs
Roche Molecular Systems, cobas® SARS-CoV-2 for use on • Commercially distributed as a kit to labs
Inc. the cobas® 6800/8800 Systems • Testing is limited to moderate and high complexity
3/12/2020 labs
Life Technologies (a part of TaqPath™ COVID-19 Combo Kit, • Commercially distributed as a kit to labs
Thermo Fisher Scientific, 100 Rxn, TaqPath™ COVID-19 • Testing is limited to high complexity labs
Inc.) Combo Kit, 1,000 Rxn
3/13/2020
Hologic, Inc. Panther Fusion SARS-CoV-2 • Reagents commercially distributed as a kit to labs
3/16/2020 Assay • Testing is limited to high complexity labs
Quidel Corporation Lyra® SARS-CoV-2 Assay • Reagents commercially distributed as a kit to labs
3/17/2020 • Testing is limited to high complexity labs
Abbott Molecular, Inc. Abbott RealTime SARS-CoV-2 • Reagents commercially distributed as a kit to labs
3/18/2020 assay • Testing is limited to high complexity labs
GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test • Reagents commercially distributed as a kit to labs
• Can run up to 24 specimens at the same time
3/19/2020 • Testing is limited to moderate and high complexity
labs
DiaSorin Molecular Simplexa COVID-19 Direct • Reagents commercially distributed as a kit to labs
LLC • Can run 1 specimen at a time
3/19/2020 • Testing is limited to moderate and high complexity
labs
Primerdesign Ltd. Primerdesign Ltd COVID-19 • Reagents commercially distributed as a kit to labs
3/20/2020 genesig Real-Time PCR • Testing is limited to high complexity labs
Cepheid Xpert Xpress SARS-CoV-2 test • Reagents commercially distributed as a kit to labs
• Can run up to 2,000 samples per day
• Testing is limited to moderate and high complexity
labs and Point of Care (POC) settings operating
3/20/2020 under a CLIA Certificate of Waiver
Mesa Biotech Inc Accula SARS-CoV-2 Test • Reagents commercially distributed as a kit to labs
• Runs one specimen at a time
• Testing is limited to moderate and high complexity
labs and Point of Care (POC) settings operating
3/23/2020 under a CLIA Certificate of Waiver
Newest authorizations are in bold 4Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
BioFire Defense, LLC BioFire COVID-19 Test • Reagents commercially distributed as a kit to labs
• Can run up to 264 tests per day
3/23/2020 • Can be run in moderate or high complexity labs
PerkinElmer, Inc. PerkinElmer New Coronavirus • Reagents commercially distributed as a kit to labs
3/24/2020 Nucleic Acid Detection kit • Testing is limited to high complexity labs
Avellino Labs USA AvellinoCoV2 test • Testing is limited to Avellino lab USA, Inc., which is a
high complexity lab
3/25/2020
BGI Genomics Co. Ltd. Real-Time Fluorescent RT-PCR • Reagents commercially distributed as a kit to labs
Kit for Detecting SARS-2019- • Testing is limited to high complexity labs
3/26/2020 nCoV
Luminex Molecular NxTAG CoV Extended Panel • Reagents commercially distributed as a kit to labs
Diagnostics, Inc. Assay • Testing is limited to high complexity labs
3/27/2020
Abbott Diagnostics ID NOW™ COVID-19 • Reagents commercially distributed as a kit
Scarborough, Inc. • Requires a specific platform (ID NOW)
• Runs one specimen at a time; each takesUpdated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Co-Diagnostics, Inc. Logix Smart Coronavirus • Reagents commercially distributed as a kit to labs
4/3/2020 Disease 2019 (COVID-19) kit • Testing is limited to high complexity labs
Gnomegen LLC Gnomegen COVID-19 RT-Digital • Reagents commercially distributed as a kit to labs
4/6/2020 PCR Detection Kit • Testing is limited to high complexity labs
InBios International, Inc Smart Detect SARS-CoV-2 rRT- • Reagents commercially distributed as a kit to labs
4/7/2020 PCR Kit • Testing is limited to high complexity labs
DiaCarta, Inc. QuantiVirus SARS-CoV-2 Test kit • Reagents commercially distributed as a kit to labs
4/8/2020 • Testing is limited to high complexity labs
Becton, Dickinson & BD SARS-CoV Reagents for BD • Reagents commercially distributed as a kit to labs
Company (BD) MAX System • Testing is limited to moderate and high complexity
4/8/2020 labs
Atila BioSystems, Inc. iAMP COVID-19 Detection Kit • Reagents commercially distributed as a kit to labs
4/10/2020 • Testing is limited to high complexity labs
Newest authorizations are in bold 6Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit • Reagents commercially distributed as a kit to labs
(USA) LLC • Testing is limited to high complexity labs
4/15/2020
GenoSensor, LLC. GS™ COVID-19 RT-PCR KIT • Reagents commercially distributed as a kit to labs
4/16/2020 • Testing is limited to high complexity labs
KorvaLabs Inc. Curative-Korva SARS-Cov-2 • Laboratory Developed Test
Assay • Testing is limited to KorvaLabs, Inc., a certified high
4/16/2020 complexity laboratory
Fosum Pharma USA Inc. Fosun COVID-19 RT-PCR • Reagents commercially distributed as a kit to labs
4/17/2020 Detection Kit • Testing is limited to high complexity labs
OSANG Healthcare GeneFinder COVID-19 Plus • Reagents commercially distributed as a kit to labs
4/18/2020 RealAmp Kit • Testing is limited to high complexity labs
Trax Management Services PhoenixDx 2019-CoV • Reagents commercially distributed as a kit to labs
Inc. • Testing is limited to high complexity labs
4/20/2020
Seegene, Inc. Allplex 2019-nCoV Assay • Reagents commercially distributed as a kit to labs
4/21/2020 • Testing is limited to high complexity labs
altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR • Reagents commercially distributed as a kit to labs
4/22/2020 Kits U.S. • Testing is limited to high complexity labs
SD Biosensor, Inc. STANDARD M nCoV Real-Time • Reagents commercially distributed as a kit to labs
4/23/2020 Detection Kit • Testing is limited to high complexity labs
SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit • Reagents commercially distributed as a kit to labs
4/27/2020 • Testing is limited to high complexity labs
Rheonix, Inc. Rheonix COVID-19 MDxAssay • Reagents commercially distributed as a kit to labs
4/29/2020 • Testing is limited to high complexity labs
LabGenomics Co., Ltd. LabGunCOVID-19 RT-PCR Kit • Reagents commercially distributed as a kit to labs
4/29/2020 • Testing is limited to high complexity labs
Bio-Rad Laboratories, Inc. Bio-Rad SARS-CoV-2 ddPCR Test • Reagents commercially distributed as a kit to labs
5/1/2020 • Testing is limited to high complexity labs
BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 • Reagents commercially distributed as a kit to labs
5/1/2020 (RP2.1) • Testing is limited to moderate and high complexity
labs
Sansure BioTech Inc. Novel Coronavirus (2019-nCoV) • Reagents commercially distributed as a kit to labs
Nucleic Acid Diagnostic Kit • Testing is limited to high complexity labs
5/4/2020 (PCR-Fluorescence Probing)
Fast Track Diagnostics FTD SARS-CoV-2 • Reagents commercially distributed as a kit to labs
Luxembourg S.á.r.l. (a • Testing is limited to high complexity labs
Siemens Healthineers
Company)
5/5/2020
Sherlock Biosciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit • Reagents commercially distributed as a kit to labs
5/6/2020 • Testing is limited to high complexity labs
OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test • Reagents commercially distributed as a kit to labs
5/6/2020 • Testing is limited to high complexity labs
Newest authorizations are in bold 7Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
BioMérieux SA SARS-COV-2 R-GENE • Reagents commercially distributed as a kit to labs
5/6/2020 • Testing is limited to high complexity labs
Zymo Research Quick SARS-CoV-2rRT-PCR Kit • Reagents commercially distributed as a kit to labs
Corporation • Testing is limited to high complexity labs
5/7/2020
Gnomegen LLC Gnomegen COVID-19-RT-qPCR • Reagents commercially distributed as a kit to labs
5/8/2020 Detection Kit • Testing is limited to high complexity labs
Abbott Molecular Inc. Alinity m SARS-CoV-2 assay • Reagents commercially distributed as a kit to labs
5/11/2020 • Testing is limited to high complexity labs
1drop Inc. 1copy COVID-19 qPCR Multi Kit • Reagents commercially distributed as a kit to labs
5/11/2020 • Testing is limited to high complexity labs
Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit • Reagents commercially distributed as a kit to labs
5/13/2020 • Testing is limited to high complexity labs
GeneMatrix, Inc. NeoPlex COVID-19 Detection • Reagents commercially distributed as a kit to labs
5/14/2020 Kit • Testing is limited to high complexity labs
Hologic, Inc. Aptima SARS-CoV-2 assay • Reagents commercially distributed as a kit to labs
5/14/2020 • Testing is limited to high complexity labs
Quidel Corporation Lyra Direct SARS-CoV-2 Assay • Reagents commercially distributed as a kit to labs
5/18/2020 • Testing is limited to high complexity labs
Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid • Reagents commercially distributed as a kit to labs
5/21/2020 Detection Kit • Testing is limited to high complexity labs
SolGent Co., Ltd DiaPlexQ Novel Coronavirus • Reagents commercially distributed as a kit to labs
5/21/2020 (2019-nCoV) Detection Kit • Testing is limited to high complexity labs
BioCore Co., Ltd BioCore 2019-nCoV Real Time • Reagents commercially distributed as a kit to labs
5/21/2020 PCR Kit • Testing is limited to high complexity labs
Dba SpectronRx Hymon SARS-CoV-2 Test Kit • Reagents commercially distributed as a kit to labs
5/22/2020 • Testing is limited to high complexity labs
Genetron Health (Beijing) Genetron SARS-CoV-2 RNA Test • Reagents commercially distributed as a kit to labs
Co., Ltd. • Testing is limited to high complexity labs
6/5/2020
Euroimmun US, Inc. EURORealTime SARS-Cov-2 • Reagents commercially distributed as a kit to labs
6/8/2020 • Testing is limited to high complexity labs
ChromaCode Inc. HDPCR SARS-CoV-2 Assay • Reagents commercially distributed as a kit to labs
6/9/2020 • Testing is limited to high complexity labs
Illumina, Inc. Illumina COVIDSeq Test • Reagents commercially distributed as a kit to labs
6/9/2020 • Testing is limited to high complexity labs
Cue Health Inc. Cue COVID-19 Test • Reagents commercially distributed as a kit to labs
• Testing is limited to moderate and high complexity
labs and Point of Care (POC) settings operating
6/10/2020 under a CLIA Certificate of Waiver
TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit • Reagents commercially distributed as a kit to labs
6/10/2020 • Testing is limited to high complexity labs
Newest authorizations are in bold 8Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Tide Laboratories, LLC DTPM COVID-19 RT-PCR Test • Developed and run at Tide Laboratories; not
distributed to other labs
• Testing is limited to authorized high complexity labs
6/10/2020
RTA Laboratories Biological Diagnovital SARS-CoV-2 Real- • Reagents commercially distributed as a kit to labs
Products Pharmaceutical Time PCR Kit • Testing is limited to high complexity labs
and Machinery Industry
6/12/2020
Applied BioCode, Inc. BioCode SARS-CoV-2 Assay • Reagents commercially distributed as a kit to labs
6/15/2020 • Testing is limited to high complexity labs
The Ohio State University OSUWMC COVID-19 RT-PCR • Laboratory developed test.
Wexner Medical Center test • Testing is limited to The Ohio State University
Wexner Medical Center in Columbus, OH, which is a
6/17/2020 high complexity lab.
Omnipathology Solutions Omni COVID-19 Assay by RT- • Laboratory developed test.
Medical Corporation PCR • Testing is limited to the Omnipathology Solutions
Medical Corporation in Pasadena, CA, which is a
6/17/2020 high complexity lab.
Jiangsu Bioperfectus COVID-19 Coronavirus Real • Reagents commercially distributed as a kit to labs
Technologies Co., Ltd. Time PCR Kit • Testing is limited to high complexity labs
6/18/2020
3B Blackbio Biotech India TRUPCR SARS-CoV-2 Kit • Reagents commercially distributed as a kit to labs
Ltd., a subsidiary of Kilpest • Testing is limited to high complexity labs
India Ltd.
6/18/2020
Gencurix, Inc. GenePro SARS-CoV-2 Test • Reagents commercially distributed as a kit to labs
6/23/2020 • Testing is limited to high complexity labs
University of Alabama at FRL SARS CoV-2 Test • Laboratory developed test.
Birmingham Fungal • Testing is limited to the UAB Fungal Reference Lab,
Reference Lab which is a high complexity lab.
6/23/2020
HealthQuest Esoterics HealthQuest Esoterics TaqPath • Laboratory developed test.
SARS-CoV-2 Assay • Testing is limited to HealthQuest Esoterics, which is
6/23/2020 a high complexity lab.
University of Texas MD MD Anderson High-throughput • Laboratory developed test.
Anderson Cancer Center, SARS-CoV-2 RT-PCR Assay • Testing is limited to the University of Texas MD
Molecular Diagnostics Anderson Cancer Center, Molecular Diagnostics
Laboratory Laboratory, which is a high complexity lab.
6/24/2020
Diagnostic Solutions DSL COVID-19 Assay • Laboratory developed test.
Laboratory, LLC • Testing is limited to the Diagnostic Solutions
Laboratory, LLC in Alpharetta, GA, which is a high
6/25/2020 complexity lab.
PlexBio Co., Ltd. IntelliPlex SARS-CoV-2 • Reagents commercially distributed as a kit to labs.
6/25/2020 Detection Kit • Testing is limited to high complexity labs.
Newest authorizations are in bold 9Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
PreciGenome LLC FastPlex Triplex SARS-CoV-2 • Reagents commercially distributed as a kit to labs.
6/25/2020 detection kit (RT-Digital PCR) • Testing is limited to high complexity labs.
Inform Diagnostic, Inc. Inform Diagnostics SARS-CoV-2 • Laboratory developed test.
RT-PCR Assay • Testing is limited to Informed Diagnostics, Inc. in
6/25/2020 Pheonix, AZ, which is a high complexity lab.
Acupath Laboratories, Inc. Acupath COVID-19 Real-Time • Laboratory developed test.
(RT-PCR) Assay • Testing is limited to Acupath Laboratories, Inc. in
6/29/2020 Plainview, NY, which is a high complexity lab.
LifeHope Labs LifeHope 2019-nCoV Real-Time • Laboratory developed test.
6/29/2020 RT-PCR Diagnostic Panel • Testing is limited to LifeHope Labs in Plainview, NY
which is a high complexity lab.
TNS Co., Ltd (Bio TNS) COVID-19 RT-PCR Peptide • Reagents commercially distributed as a kit to labs
6/30/2020 Nucleic Acid (PNA) kit • Testing is limited to high complexity labs.
Psomagen, Inc. Psoma COVID-19 RT Test • Laboratory developed test.
• Testing is limited to Psomagen, Inc. in Rockville, MD,
6/30/2020 which is a high complexity lab.
CENTOGENE US, LLC CentoFast-SARS-CoV-2 RT-PCR • Laboratory developed test.
Assay • Testing is limited to CENTOGENE US, LLC, which is a
high complexity lab, or other high complexity
7/1/2020 laboratories designated by CENTOGENE US, LLC.
Centers for Disease Control Influenza SARS-CoV-2 (Flu SC2) • Reagents commercially distributed as a kit to labs.
and Prevention (CDC) Multiplex Assay • For use in the detection and differentiation of SARS-
CoV-2, influenza A, and/or influenza B in upper and
lower respiratory specimens.
7/2/2020 • Testing is limited to high complexity labs.
Laboratorio Clinico Toledo Laboratorio Clinico Toledo • Laboratory developed test.
SARS-CoV-2 Assay • Testing is limited to Laboratorio Clinico Toledo,
7/6/2020 which is a high complexity lab in Arecibo, PR.
Gene By Gene Gene By Gene SARS-CoV-2 • Laboratory developed test.
Detection Test • Testing is limited to Gene By Gene laboratory, which
7/7/2020 is a high complexity laboratory in Houston, TX.
Access Bio, Inc. CareStart COVID-19 MDx RT- • Reagents commercially distributed as a kit to labs.
7/7/2020 PCR • Testing is limited to high complexity labs.
Enzo Life Sciences, Inc. AMPIPROBE SARS-CoV-2 Test • Reagents commercially distributed as a kit to labs.
7/7/2020 System • Testing is limited to high complexity labs.
Clinical Research CRSP SARS-CoV-2 Real-time • Laboratory developed test.
Sequencing Platform Reverse Transcriptase (RT)-PCR • Testing is limited to the Clinical Research
(CRSP), LLC at the Broad Diagnostic Assay Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Institute of MIT and Harvard, which is a high
Harvard complexity laboratory located in Cambridge, MA.
7/8/2020
BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit • Reagents commercially distributed as a kit to labs.
7/9/2020 • Testing is limited to high complexity labs.
Newest authorizations are in bold 10Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
UCSF Health Clinical SARS-CoV-2 RNA DETECTR • Laboratory developed test.
Laboratories, UCSF Clinical Assay • Testing is limited to the UCSF Clinical Labs at China
Labs at China Basin Basin, which is a high complexity laboratory located
7/9/2020 in San Francisco, CA.
Boston Medical Center BMC-CReM COVID-19 Test • Laboratory developed test.
• Testing is limited to the Boston Medical
Center/Department of Pathology and Laboratory
Medicine, which is a high complexity laboratory
7/10/2020 located in Boston, MA.
KogeneBiotech Co., Ltd. PowerChek 2019-nCoV Real- • Reagents commercially distributed as a kit to labs.
7/13/2020 time PCR Kit • Testing is limited to high complexity labs.
Trax Management Services PhoenixDx SARS-CoV-2 • Reagents commercially distributed as a kit to labs.
Inc. Multiplex • Testing is limited to high complexity labs.
7/13/2020
Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR • Laboratory developed test.
Test • Testing is limited to Boston Heart Diagnostics, which
is a high complexity laboratory located in
7/16/2020 Framingham, MA.
Access Genetics, LLC OraRisk COVID-19 RT-PCR • Laboratory developed test.
• Testing is limited to Access Genetics, LLC, which is a
high complexity laboratory located in Eden Prairie,
7/17/2020 MN.
DiaCarta, Inc. QuantiVirus SARS-CoV-2 • Reagents commercially distributed as a kit to labs.
7/21/2020 Multiplex Test Kit • Testing is limited to high complexity labs.
Helix OpCo LLC (dba Helix) Helix COVID-19 Test • Laboratory developed test.
7/23/202 • Testing is limited to the Helix Laboratory, which is a
high complexity laboratory located in San Diego, CA.
Jiangsu CoWin Biotech Co., Novel Coronavirus (SARS-CoV-2) • Reagents commercially distributed as a kit to labs.
Ltd. Fast Nucleic Acid Detection Kit • Testing is limited to high complexity labs.
7/24/2020 (PCR-Fluorescence Probing)
Sandia National Laboratories SNL-NM 2019 nCoV Real-Time • Laboratory developed test.
7/27/2020 RT-PCR Diagnostic Assay • Testing is limited to Sandia National Laboratories’
laboratory, which is a high complexity laboratory
located in Albuquerque, NM.
Eli Lilly and Company Lilly SARS-CoV-2 Assay • Reagents commercially distributed as a kit to labs.
7/27/2020 • Testing is limited to high complexity labs.
University of California San UCSD RC SARS-CoV-2 Assay • Laboratory developed test.
Diego Health • Testing is limited to the University of California San
7/31/2020 Diego Health laboratory, which is a high complexity
laboratory located in San Diego, CA.
Xiamen Zeesan Biotech Co., SARS-CoV-2 Test Kit (Real-time • Reagents commercially distributed as a kit to labs.
Ltd. PCR) • Testing is limited to high complexity labs.
7/31/2020
ISPM Labs, LLC dba • Laboratory developed test.
Capstone Healthcare Genus SARS-CoV-2 Assay
8/03/2020
Newest authorizations are in bold 11Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
• Testing is limited to the Clinical Virology Laboratory
at Capstone Healthcare laboratory, which is a high
complexity laboratory located in Sandy Springs, GA.
• Laboratory developed test.
Poplar Healthcare Poplar SARS-CoV-2 TMA Pooling • Testing is limited to the Poplar Healthcare
8/03/2020 assay laboratory, which is a high complexity laboratory
located in Memphis, TN.
Cleveland Clinic Robert J. • Laboratory developed test.
Tomsich Pathology and • Testing is limited to the Robert J. Tomsich Pathology
Cleveland Clinic SARS-CoV-2
Laboratory Medicine and Laboratory Medicine Institute, which is a high
Assay
Institute complexity laboratory located in Cleveland, OH.
8/03/2020
• Laboratory developed test.
Ethos Laboratories Ethos Laboratories SARS-CoV-2
• Testing is limited to the Ethos Laboratory, which is a
8/03/2020 MALDI-TOF Assay
high complexity laboratory located in Newport, KY.
Wren Laboratories LLC Wren Laboratories COVID-19 PCR • Laboratory developed test.
8/3/2020 Test • Testing is limited to the Ethos Laboratory, which is a
high complexity laboratory located in Newport, KY.
Vela Operations Singapore ViroKey SARS-CoV-2 RT-PCR Test • Reagents commercially distributed as a kit to labs.
Pte Ltd • Testing is limited to high complexity labs.
8/5/2020
Helix OpCo LLC (dba Helix) Helix COVID-19 NGS Test • La boratory developed test.
• Testing is limited to Helix Laboratory, which is a high
8/6/2020 complexity laboratory located in San Diego, CA.
George Washington GWU SARS-CoV-2 RT-PCR Test • La boratory developed test.
University Public Health • Testing is limited to the George Washington
La boratory University Public Health Laboratory, which is a high
08/07/2020 complexity laboratory located in Washington, DC.
Alpha Genomix Ta qPath SARS-CoV-2 Combo • La boratory developed test.
La boratories Assay • Testing is limited to the Alpha Genomix Laboratories,
which is a high complexity laboratory located in
08/10/2020 Peachtree Corners, GA.
Solaris Diagnostics Solaris Multiplex SARS-CoV-2 • La boratory developed test.
08/10/2020 Assay • Testing is limited to Solaris Diagnostics, which is a
high complexity laboratory located in Nicholasville,
KY .
LumiraDx UK Ltd. SARS-CoV-2 RNA STAR • Reagents commercially distributed as a kit to labs.
08/11/2020 • Testing is limited to high complexity labs.
B iomeme, Inc. SARS-CoV-2 Real-Time RT-PCR • Reagents commercially distributed as a kit to labs.
08/11/2020 Test • Testing is limited to high complexity labs.
Pro-Lab Diagnostics Pro-Amp RT SARS-CoV-2 Test • La boratory developed test.
08/13/2020 • Testing is limited to Pro-Lab Diagnostics, which is a
high complexity laboratory located in Round Rock,
TX.
Newest authorizations are in bold 12Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Y a le School of Public Sa livaDirect • D etection of SARS-CoV-2 virus in saliva collected
Health, Department of without preservative.
Epidemiology of Microbial • Instructions for use distributed to labs; components
D iseases a re all commercially available.
08/15/2020 • Testing is limited to high complexity laboratories
designated the Yale School of Public Health.
ZhuHai Sinochips C OVID-19 Nucleic Acid RT-PCR • Reagents commercially distributed as a kit to labs.
B ioscience Co., Ltd. Test Kit • Testing is limited to high complexity labs.
08/17/2020
Texas Department of State D SHS SARS-CoV-2 Assay • La boratory developed test.
Health Services, Laboratory • Testing is limited to Texas Department of State
Services Section Health Services, which is a high complexity
la boratory located in Austin, TX.
08/21/2020
D xTerity Diagnostics, Inc. SARS-CoV-2 RT-PCR Test • D etection of SARS-CoV-2 virus in saliva.
• La boratory developed test.
• Testing is limited to DxTerity Diagnostics, Inc., which
08/21/2020 is a high complexity laboratory located in Rancho
D ominguez, CA.
Guardant Health, Inc. Guardant-19 • La boratory developed test.
• Testing is limited to Guardant Health Clinical
08/21/2020 La boratory, which is a high complexity laboratory
located in Redwood City, CA.
Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR • D etection of SARS-CoV-2 virus in saliva.
Assay • Reagents commercially distributed as a kit to labs.
08/25/2020 • Testing is limited to high complexity labs.
D IAGNOSTICS – MOLECULAR – HOME COLLECTION
Can be used with specimens that are self-collected at home with specific collection kits, then sent to the lab for testing.
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Laboratory Corporation of COVID-19 RT-PCR Test • Developed and run in high complexity LabCorp labs
America only; not for broader lab distribution
COVID-19 RT-PCR Amendment • Amendment permits use of the Pixel by LabCorp
COVID-19 test home collection kit allowing patients
to self-collect nasal swab specimens at home
• The kit provides specimen collection materials and
3/16/2020 materials to safely send specimens to an authorized
Amended 4/ 20/2020 laboratory
Newest authorizations are in bold 13Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Quest Diagnostics SARS-CoV-2 RNA, Qualitative • Developed and run in Quest labs only; not a kit for
Infectious Disease, Inc. Real-Time RT-PCR distribution.
3/17/2020 • Testing is limited to high complexity labs
Rutgers Clinical Genomics Rutgers Clinical Genomics • Laboratory developed test
Laboratory at RUCDR Laboratory TaqPath SARS-CoV- • Testing is limited to Rutgers Clinical Genomics
Infinite Biologics - Rutgers 2-Assay Laboratory at RUCDR Infinite Biologics, which is a
University high complexity lab
5/7/2020 • First diagnostic test using at-home collection of
saliva specimens
Everlywell, Inc. Everlywell COVID-19 Test • For use by individuals to self-collect nasal swab
Home Collection Kit specimens at home, when determined by a
healthcare provider to be appropriate based on
results of a COVID-19 questionnaire, and
• For use only with in vitro diagnostic (IVD) molecular
tests for the detection of SARS-CoV-2 RNA that are
indicated for use with the Everlywell COVID-19
5/15/2020 Home Collection Kit.
Assurances Scientific Assurance SARS-CoV-2 Panel • Laboratory developed test
Laboratories • Testing is limited to Assurance Scientific, which is a
high complexity lab
• Can be used with nasal swab specimens that are
5/15/2020 self-collected at home with the Everlywell home
collection kit, then sent to the lab for testing.
Fulgent Therapeutics, LLC. Fulgent COVID-19 by RT-PCR • Laboratory developed test
Test • Testing is limited to Fulgent Therapeutics high
complexity lab
• Can be used with nasal swab specimens that are
5/15/2020 self-collected at home with the Everlywell home
collection kit, then sent to the lab for testing.
Newest authorizations are in bold 14Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
P23 Labs, LLC. P23 Labs TaqPath SARS-CoV-2 • Laboratory developed test
Assay • Testing is limited to P23 Labs, LLC, located in Little
Rock, AK, which is a high complexity lab
• Can be used with saliva specimens that are self-
collected at home with the OMNIgene ORAL OM-
5/21/2020 505 Collection Device, then sent to the lab for
testing.
PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus • Laboratory developed test
(COVID-19) Test • Testing is limited to PrivaPath Labs d.b.a. LGC Labs,
which is a high complexity lab.
• Can only be used with nasal swabs included with
5/28/2020 the LetsGetChecked COVID-19 Home Collection Kit,
then sent to the lab for testing.
Phosphorus Diagnostics, Phosphorus COVID-19 RT-qPCR • Laboratory developed test
LLC. Test • Testing is limited to Phosphorus Diagnostics, LLC,
located in Secaucus, NJ, which is a high complexity
lab.
• Can be used with saliva specimens that are
6/4/2020 collected at home or in a healthcare setting using
the Oragene Dx OGD-510 collection device, when
determined to be appropriate by a HCP.
Kaiser Permanente Mid- KPMAS COVID-19 Test • Laboratory developed test
Atlantic States • Testing is limited to KPMAS Regional Laboratory,
Rockville, MD
• Can be used with nasal swab specimens self-
collected by KPMAS Health Plan members observed
at home via telemedicine, using the KPMAS COVID-
6/13/2020 19 Home Collection Kit, when determined to be
appropriate by a healthcare provider.
The Kroger Co. Kroger Health COVID-19 Test • Laboratory developed test
Home Collection Kit • Testing is limited to laboratories designated by The
Kroger Co. that meet requirements to perform high
complexity tests and that run the specimens
collected from the Kroger Health COVID-19 Test
6/30/2020 Home Collection Kit on an in vitro diagnostic (IVD)
molecular test that is indicated for use with the
Kroger Health COVID-19 Test Home Collection Kit
for self-collection of nasal swab specimens
• Can be used with nasal swab specimens self-
collected at home, video observed by a healthcare
provider using the Kroger Health COVID-19 Test
Home Collection Kit
Newest authorizations are in bold 15Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Compass Laboratory Compass Laboratory Services • Laboratory developed test
Services, LLC SARS-CoV2 Assay • Testing is limited to Compass Laboratory Services,
7/13/2020 LLC, which is a high complexity lab in Memphis, TN.
• Can be used with nasal swab specimens self-
collected at home, video observed by a healthcare
provider using an authorized home collection kit
specified in the authorized labeling.
Quest Diagnostics Quest Diagnostics HA SARS- • Laboratory developed test
Infectious Disease, Inc. CoV-2 Assay • Testing is limited to laboratories designated by
7/15/2020 Quest Diagnostics that meet the requirements to
perform high complexity tests.
• Can be used with nasal swab specimens self-
collected at home under healthcare provider
supervision using the Quest Diagnostics Self-
Collection Kit for COVID-19.
Quest Diagnostics Quest Diagnostics RC SARS- • Laboratory developed test
Infectious Disease, Inc. CoV-2 Assay • Testing is limited to laboratories designated by
7/15/2020 Quest Diagnostics that meet the requirements to
perform high complexity tests.
• Can be used with nasal swab specimens self-
collected at home under healthcare provider
supervision using the Quest Diagnostics Self-
Collection Kit for COVID-19.
Quest Diagnostics Quest Diagnostics PF SARS- • Laboratory developed test
Infectious Disease, Inc. CoV-2 Assay • Testing is limited to laboratories designated by
Quest Diagnostics that meet the requirements to
perform high complexity tests.
• Can be used with nasal swab specimens self-
collected at home under healthcare provider
supervision using the Quest Diagnostics Self-
Collection Kit for COVID-19.
Clinical Reference CRL Rapid Response • Laboratory developed test
Laboratory, Inc. • Testing is limited to the Clinical Reference Library
7/30/2020 lab located in Lenexa, KS, which is a high complexity
lab.
• Can be used with self-collected saliva samples
collected at home or under healthcare provider
supervision when determined to be appropriate by
a health care provider using the CRL COVID-19 Self
Collection Testing Kit.
Newest authorizations are in bold 16Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Ethos Laboratories Ethos Laboratories SARS-CoV-2 • Laboratory developed test
8/3/2020 MALDI-TOF Assay • Testing is limited to the Ethos Laboratory lab
located in Newport, KY, which is a high complexity
lab.
• Can be used with nasal swab specimens self-
collected at home when prescribed by a healthcare
provider based on the results of an online
questionnaire or office visit using the Ethos
Laboratories U-Collect At Home Collections kit.
QD x Pathology Services QD X SARS-CoV-2 Assay • La boratory developed test
8/25/2020 • Testing is limited to QDx Pathology Services located
in Cranford, NJ, which is a high complexity lab.
• Can be used with specimens collected at home using
the Qdetect home collection kit, or other authorized
home-collection kit specified in the authorized
la beling, by individuals suspected of COVID-19 when
home collection is determined to be appropriate by
a healthcare provider.
UMBRELLA EUA FOR MOLECULAR DIAGNOSTIC TESTS FOR SARS-COV-2 DEVELOPED AND PERFORMED BY LABORATORIES
C ERTIFIED UNDER CLIA TO PERFORM HIGH COMPLEXITY TESTS
On March 31, 2020, the FDA concluded based on the totality of scientific evidence available that molecular-based
laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to
protect the public health or safety (as described under the Scope of Authorization (Section II)) under section 564 of the
Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3). Under this EUA, authorized tests are authorized for
use in the single laboratory that developed the authorized test and that is certified under Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.
LABORATORIES (DATE OF AUTHORIZATION)
• AIT Laboratories (4/24/2020)
• Altru Diagnostics (4/30/2020)
• Aspirus Reference Laboratory (6/1/2020)
• Avera Institute for Human Genetics (5/22/2020)
• Biocerna (4/28/2020)
• Biocollections Worldwide, Inc. (5/07/2020)
• Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine (5/13/2020)
• CirrusDx SARS-CoV-2 Assay (4/15/2020)
• Color Genomics, Inc. (5/18/2020)
• Columbia University Laboratory of Personalized Genomic Medicine (5/12/2020)
• Cormeum Laboratory Services (6/12/2020)
• CSI Laboratories (06/02/2020)
• Diagnostic Molecular Laboratory-Northwestern Medicine (4/02/2020)
• Diatherix Eurofins Laboratory (4/22/2020)
• Exact Sciences Laboratories (4/14/2020), Amendment (5/22/2020)
Newest authorizations are in bold 17Updated August 25, 2020
• Express Gene LLC (dba Molecular Diagnostics Laboratory) (5/22/2020)
• Gravity Diagnostics, LLC (06/01/2020)
• Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory (4/15/2020)
• Hangzhou Biotest Biotech Co., Ltd. (6/4/2020)
• Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children’s Hospital (4/14/2020)
• Infectious Disease Diagnostics Laboratory-Children’s Hospital of Philadelphia (4/02/2020)
• Integrity Laboratories (4/13/2020)
• Massachusetts General Hospital (Mass Gen) (4/03/2020)
• Mayo Clinic Laboratories, Rochester, MN (04/20/2020)
• Nationwide Children’s Hospital (4/27/2020)
• Nebraska Medicine Clinical Laboratory (6/4/2020)
• One Health Laboratories (5/13/2020)
• Orig3n, Inc.(4/10/2020)
• Pathology/Laboratory Medicine Lab of Baptist Hospital Miami (4/13/2020)
• Southwest Regional PCR Laboratory LLC. PCR MicroGen DX (4/23/2020)
• Specialty Diagnostic (SDI) Laboratories (4/10/2020)
• Stanford Health Care Clinical Virology Laboratory (4/08/2020)
• Ultimate Dx Laboratory (4/24/2020)
• University of North Carolina Medical Center (4/10/2020)
• UTMG Pathology Laboratory (5/01/2020)
• Viracor Eurofins Clinical Diagnostics (4/06/2020)
• Warrior Diagnostics, Inc. (6/10/2020)
• Yale New Havel Hospital, Clinical Virology Laboratory (3/31/2020)
INDIVIDUAL EUAS FOR ANTIGEN DIAGNOSTIC TESTS FOR SARS-COV-2
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Abbott Diagnostics B inaxNOW COVID-19 Ag Card • Testing is limited to moderate and high complexity
Scarborough, Inc. la bs and POC settings operating under a CLIA
8/26/20 C ertificate of Waiver
• Visually read assay that does not require an
instrument.
LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test • Testing is limited to moderate and high complexity
la bs and POC settings operating under a CLIA
8/18/2020 C ertificate of Waiver
Becton, Dickinson and BD Veritor System for Rapid • Testing is limited to moderate and high complexity
Company (BD) Detection of SARS-CoV-2 labs and POC settings operating under a CLIA
7/2/2020 Certificate of Waiver
Quidel Corporation Sofia SARS Antigen FIA • Testing is limited to moderate and high complexity
labs and POC settings operating under a CLIA
5/8/2020 Certificate of Waiver
INDIVIDUAL EUAS FOR SEROLOGY TESTS FOR SARS-COV-2
Newest authorizations are in bold 18Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Cellex Inc. Serology Test qSARS-CoV-2 • The first serological test authorized under EUA.
IgG/IgM Rapid Test • Detects SARS-CoV-2 antibodies in blood and
differentiates between IgG and IgM antibodies.
• Rapid test provides results in 15-20 minutes.
4/1/2020 • Testing is limited to moderate and high complexity
labs.
Ortho-Clinical Diagnostics, VITROS Immunodiagnostic • Detects IgG antibodies in serum.
Inc. Products Anti-SARS-CoV-2 IgG • Testing is limited to moderate and high complexity
4/14/2020 Reagent Pack labs.
Mount Sinai Laboratory COVID-19 ELISA IgG Antibody • Detects IgG antibodies in serum and plasma.
4/15/2020 Test • Test is limited to Mount Sinai Laboratory, which is a
high complexity lab.
DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG • Detects IgG antibodies in serum and plasma.
4/24/2020 • Testing is limited to moderate and high complexity
labs.
Ortho Clinical Diagnostics, VITROS Immunodiagnostic • Detects and differentiates IgM and IgG antibodies
Inc. Products Anti-SARS-CoV-2 Total in serum and plasma
4/24/2020 Reagent Pack • Testing is limited to moderate and high complexity
labs.
Abbott Laboratories Inc. SARS-CoV-2 IgG assay • Detects IgG antibodies in serum and plasma.
4/26/2020 • Testing is limited to moderate and high complexity
labs.
Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab • Detects and differentiates IgM and IgG antibodies
assay in serum and plasma
4/29/2020 • Testing is limited to high complexity labs.
Wadsworth Center, NY New York SARS-CoV • Detects total antibodies in serum.
State Department of Microsphere Immunoassay for • Test is limited to Wadsworth Center, New York
Health Antibody Detection State Department of Health, which is a high
4/30/2020 complexity lab.
Roche Diagnostics Elecsys Anti-SARS-CoV-2 • Detects Anti-SARS-Cov-2 antibodies in serum and
plasma.
5/2/2020 • Testing is limited to moderate and high complexity
labs.
EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG) • Detects IgG antibodies in serum and plasma.
5/4/2020 • Testing is limited to high complexity labs.
Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test • Detects and differentiates IgM and IgG antibodies
Cassette (Whole in whole blood, plasma and serum.
Blood/Serum/Plasma) • Testing is limited to moderate and high complexity
5/29/2020 labs.
Siemens Healthcare Atellica IM SARS-CoV-2 Total • Detects Anti-SARS-Cov-2 antibodies in serum and
Diagnostics Inc. (COV2T) plasma.
5/29/2020 • Testing is limited to moderate and high complexity
labs.
Newest authorizations are in bold 19Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Siemens Healthcare ADVIA Centaur SARS-CoV-2 • Detects Anti-SARS-Cov-2 antibodies in serum and
Diagnostics Inc. Total (COV2T) plasma.
5/29/2020 • Testing is limited to moderate and high complexity
labs.
Vibrant America Clinical Vibrant COVID-19 Ab Assay • Detects IgG and IgM antibodies in serum and dried
Labs blood
• Testing is limited to the Vibrant America Clinical
Labs at 1360 Bayport Avenue, San Carlos, CA, which
6/4/2020 is a high complexity lab
Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM • Detects IgM and IgG antibodies in serum, plasma,
Co., Ltd. Rapid Test Cassette and venous whole blood
6/4/2020 • Testing is limited to moderate and high complexity
labs.
Siemens Healthcare Dimension EXL SARS-CoV-2 • Detects total antibodies in serum and plasma
Diagnostics Inc. Total antibody assay (CV2T) • Testing is limited to moderate and high complexity
6/8/2020 labs.
Siemens Healthcare Dimension Vista SARS-CoV-2 • Detects total antibodies in serum and plasma
Diagnostics Inc. Total antibody assay (COV2T) • Testing is limited to moderate and high complexity
6/8/2020 labs.
InBios International, Inc. SCoV-2 Detect IgG ELISA • Detects IgG antibodies in serum
6/10/2020 • Testing is limited to high complexity labs.
Emory Medical SARS-CoV-2 RBD IgG test • Detects IgG antibodies in serum.
Laboratories • Testing is limited to high complexity labs.
6/15/2020
Biohit Healthcare (Hefei) Biohit SARS-CoV-2 IgM/IgG • Detects IgM and IgG antibodies in serum, plasma,
Co. Ltd. Antibody Test Kit and venipuncture whole blood.
6/18/2020 • Testing is limited to moderate and high complexity
labs.
Hangzhou Laihe Biotech LYHER Novel Coronavirus • Detects and differentiates IgG and IgM antibodies
Co., Ltd. (2019-nCoV) IgM/IgG Antibody in serum and plasma.
6/19/2020 Combo Test Kit (Colloidal Gold) • Testing is limited to moderate and high complexity
labs.
Babson Diagnostics, Inc. Babson Diagnostics aC19G1 • Detects IgG antibodies in serum and plasma.
• Testing is limited to Babson Diagnostics, Inc. at
1205 Sheldon Cove, Suite 2-J, Austin, TX, which is a
6/23/2020 high complexity lab
Beckman Coulter, Inc. Access SARS-CoV-2 IgG • Detects IgG antibodies in serum and plasma.
• Testing is limited to moderate and high complexity
6/26/2020 labs.
InBios International, Inc. SCoV-2 Detect IgM ELISA • Detects IgM antibodies in serum.
6/30/2020 • Testing is limited to high complexity labs..
Assure Tech. (Hangzhou Assure COVID-19 IgG/IgM • Detects and differentiates IgG and IgM antibodies
Co., Ltd) Rapid Test Device in venous whole blood, serum and plasma.
7/6/2020 • Testing is limited to moderate and high complexity
labs.
Newest authorizations are in bold 20Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 • Detects IgG antibodies in serum and plasma.
7/8/2020 IgG CLIA Kit • Testing is limited to moderate and high complexity
labs.
Beijing Wantai Biological WANTAI SARS-CoV-2 Ab Rapid • Detects total antibodies in venous whole blood,
Pharmacy Enterprise Co., Test serum and plasma.
Ltd. • Testing is limited to moderate and high complexity
7/10/2020 labs.
Salofa Oy Sienna-Clarity COVIBLOCK • Detects and differentiates IgG and IgM antibodies
COVID-19 IgG/IgM Rapid Test in venous whole blood, serum and plasma.
Cassette • Testing is limited to moderate and high complexity
7/13/2020 labs.
Luminex Corporation xMAP SARS-CoV-2 Multi- • Detects IgG antibodies in serum and plasma.
7/16/2020 Antigen IgG Assay • Testing is limited to high complexity labs.
Megna Health, Inc. Rapid COVID-19 IgM/IgG • Detects and differentiates IgG and IgM antibodies
Combo Test Kit in serum and plasma.
• Testing is limited to moderate and high complexity
7/17/2020 labs.
Access Bio, Inc. CareStart COVID-19 IgM/IgG • Detects and differentiates IgG and IgM antibodies
7/24/2020 in whole blood, serum and plasma.
• Testing is limited to moderate and high complexity
labs.
Xiamen Biotime BIOTIME SARS-CoV-2 IgG/IgM • Detects and differentiates IgG and IgM antibodies
Biotechnology Co., Ltd. Rapid Qualitative Test in whole blood, serum and plasma.
7/24/2020 • Testing is limited to moderate and high complexity
labs.
Siemens Healthcare ADVIA Centaur SARS-CoV-2 IgG • Detects IgG antibodies in serum and plasma.
Diagnostics Inc. (COV2G) • Testing is limited to moderate and high complexity
7/31/2020 labs.
Siemens Healthcare Atellica IM SARS-CoV-2 IgG • Detects IgG antibodies in serum and plasma.
Diagnostics Inc. (COV2G) • Testing is limited to moderate and high complexity
7/31/2020 labs.
B eijing Wantai Biological WANTAI SARS-CoV-2 Ab ELISA • D etects total antibodies in serum and plasma.
Pharmacy Enterprise Co., • Testing is limited to high complexity labs.
Ltd.
8/05/2020
bioMérieux SA VIDAS SARS-CoV-2 IgG • D etects IgG antibodies in serum and plasma.
08/06/2020 • Testing is limited to moderate and high complexity
la bs.
bioMérieux SA VIDAS SARS-CoV-2 IgM • D etects IgM antibodies in serum and plasma.
08/06/2020 • Testing is limited to moderate and high complexity
la bs.
D iazyme Laboratories, Inc. D Z-Lite SARS-CoV-2 IgM CLIA Kit • D etects IgM antibodies in serum and plasma.
08/17/2020 • Testing is limited to moderate and high complexity
la bs.
Newest authorizations are in bold 21Updated August 25, 2020
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
B ioCheck, Inc. SARS-CoV-2 IgG and IgM Combo • D etects and differentiates IgG and IgM antibodies in
08/17/2020 Test serum.
• Testing is limited to moderate and high complexity
la bs.
B iocan Diagnostics, Inc. Tell Me Fast Novel Coronavirus • D etects and differentiates IgG and IgM antibodies in
(C OVID-19) IgG/IgM Antibody venous whole blood, serum and plasma.
08/25/2020 Test • Testing is limited to moderate and high complexity
la bs.
INDIVIDUAL EUAS FOR IVDS FOR MANAGEMENT OF COVID-19 PATIENTS
This table includes information about authorized in vitro diagnostic tests that may be used in the management of patients
with COVID-19 that have been authorized individually. These EUAs have been issued for each individual test with certain
conditions of authorization required of the manufacturer and authorized laboratories.
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Roche Diagnostics Elecsys IL-6 • To assist in identifying severe inflammatory
response in patients with confirmed COVID-19
illness to aid in determining the risk of intubation
with mechanical ventilation
6/2/2020 • Testing is limited to moderate and high complexity
labs
D ECONTAMINATION SYSTEMS FOR PERSONAL PROTECTIVE EQUIPMENT
SPONSOR PRODUCT D ESCRIPTION
(link to authorization letter)
Battelle Battelle Decontamination A single compatible respirator to be recycled and reused
System up to 20 times using the Battelle Decontamination
System
Battelle is authorized to scale up their operations to
decontaminate about 120,000 respirators daily by using
all 12 of their satellite facilities once they submit data to
3/29/2020 FDA
STERIS STERIS V-PRO 1 Plus, maX, and Decontaminates compatible N95 or N95 equivalent
maX2 Lower Temperature respirators (compatible N95 respirators) for single-user
Systems (STERIS Sterilization reuse by healthcare personnel
4/09/2020 Systems)
Newest authorizations are in bold 22You can also read
