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  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2

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Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2

On August 6, 2020, based on the FDA's continued review of the scientific evidence available for Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin / EDTA / sodium citrate) or serum 2, including evidence from an NIH/NCI independent evaluation, the FDA determined that the statutory criteria for the authorization in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, the FDA determined that it is not reasonable to believe the product may be effective in detecting IgM antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. The FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

On June 16, 2020, based on the FDA's continued review of the scientific evidence available for Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System for detection of IgM and IgG antibodies against SARS-CoV-2, including evidence from an NIH/NCI independent evaluation, the FDA determined that the statutory criteria for issuing an EUA in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, the FDA determined that it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. The FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

This table includes information about authorized SARS-CoV-2 serology/antibody tests and other adaptive immune response tests 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.

For additional performance information about EUA authorized serology/antibody tests, please see the EUA Authorized Serology Test Performance page.

Date EUA Issued or Last Updated Entity Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued Attributes3 Authorized Setting(s)1 Authorization Documents2 Other Documents Other Brand Name(s)
1/14/2021 Abbott Laboratories Inc. SARS-CoV-2 IgG assay
04/26/2020
IgG, CMIA H, M HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi None
06/12/2020 Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test
04/01/2020
IgM and IgG, Lateral Flow H, M HCP, Patients, IFU None None
03/29/2021 Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
04/14/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None
04/15/2020 Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test
04/15/2020
IgG, ELISA H HCP, Patients, EUA Summary None None
10/19/2020 DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG
04/24/2020
IgG, CLIA H, M HCP, Recipients, IFU None
02/12/2021 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
04/24/2020
IgG, CLIA H, M HCP, Recipients, IFU None
10/30/2020 Bio-Rad Laboratories, Inc. Platelia SARS-CoV-2 Total Ab assay
04/29/2020
Total Antibody, ELISA H HCP, Recipients, IFU None
04/30/2020 Wadsworth Center, New York State Department of Health New York SARS-CoV Microsphere Immunoassay for Antibody Detection
04/30/2020
Total Antibody, FMIA H HCP, Recipients, EUA Summary None None
10/23/2020 Roche Diagnostics Elecsys Anti-SARS-CoV-2
05/02/2020
Total Antibody, ECLIA H, M HCP, Recipients, IFU None
05/04/2020 EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG)
05/04/2020
IgG, ELISA H HCP, Recipients, IFU None None
05/29/2020 Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
05/29/2020
IgM and IgG Lateral Flow H, M HCP, Recipients, IFU None None
05/29/2020 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 Total (COV2T)
05/29/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None None
05/29/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 Total (COV2T)
05/29/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None None
06/04/2020 Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay
06/04/2020
IgM and IgG, CLIA H HCP, Recipients, EUA Summary None None
12/21/2020 Hangzhou Biotest Biotech Co., Ltd. RightSign COVID-19 IgG/IgM Rapid Test Cassette
06/04/2020
IgM and IgG Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU 
  • Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette
  • CoronaCHEK COVID-19 IgG/IgM Rapid Test Cassette
10/30/2020 Siemens Healthcare Diagnostics Inc. Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
06/08/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None
10/30/2020 Siemens Healthcare Diagnostics Inc. Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
06/08/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None
06/10/2020 InBios International, Inc. SCoV-2 Detect IgG ELISA
06/10/2020
IgG, ELISA H HCP, Recipients, IFU None None
06/15/2020 Emory Medical Laboratories SARS-CoV-2 RBD IgG test
06/15/2020
IgG, ELISA H HCP, Recipients, EUA Summary None None
10/17/2020 Biohit Healthcare (Hefei) Co. Ltd. Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
06/18/2020
IgM and IgG Lateral Flow H, M HCP, Recipients, IFU ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit
12/02/2020 Hangzhou Laihe Biotech Co., Ltd. LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
06/19/2020
IgM and IgG Lateral Flow H, M HCP, Recipients, IFU QUICKKIT Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
06/23/2020 Babson Diagnostics, Inc. Babson Diagnostics aC19G1
06/23/2020
IgG, CLIA H HCP, Recipients, EUA Summary None None
06/26/2020 Beckman Coulter, Inc. Access SARS-CoV-2 IgG
06/26/2020
IgG, CLIA H, M HCP, Recipients, IFU None None
03/25/2021 InBios International, Inc. SCoV-2 Detect IgM ELISA
06/30/2020
IgM, ELISA H HCP, Recipients, IFU None None
09/23/2020 Assure Tech. (Hangzhou Co., Ltd) Assure COVID-19 IgG/IgM Rapid Test Device
07/06/2020
IgM and IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None
  • Ecotest COVID-19 IgG/IgM Rapid Test Device
  • Fastep COVID-19 IgG/IgM Rapid Test Device
03/22/2021 Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit
07/08/2020
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None None
03/12/2021 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab Rapid Test
07/10/2020
Total Antibody, Lateral Flow H, M HCP, Recipients, IFU None None
01/05/2021 Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
07/13/2020
IgM and IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None
  • Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
  • Sienna COVID-19 IgG/IgM Rapid Test Cassette
07/16/2020 Luminex Corporation xMAP SARS-CoV-2 Multi-Antigen IgG Assay
07/16/2020
IgG, FMIA H HCP, Recipients, IFU None None
04/22/2021 Megna Health, Inc. Rapid COVID-19 IgM/IgG Combo Test Kit
07/17/2020
IgM and IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None None
11/06/2020 Xiamen Biotime Biotechnology Co., Ltd. BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
07/24/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU
  • Telepoint SARS-CoV-2 IgG/IgM Rapid Qualitative Test
04/22/2021 Access Bio, Inc. CareStart COVID-19 IgM/IgG
07/24/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU
  • Rapid Response Liberty COVID-19 IgG/IgM
  • AQSign COVID-19 IgG/IgM
  • Easy Check COVID-19 IgM/IgG
  • KarmaCare COVID-19 IgM/IgG
07/31/2020 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 IgG (COV2G)
07/31/2020
IgG, Semi-quantitative H, M

HCP, Recipients, IFU

None None
07/31/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 IgG (COV2G)
07/31/2020
IgG, Semi-quantitative H, M HCP, Recipients, IFU None None
08/05/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab ELISA
08/05/2020
Total Antibody, ELISA H HCP, Recipients, IFU None None
03/15/2021 bioMérieux SA VIDAS SARS-CoV-2 IgM
08/06/2020
IgM, ELFA H, M HCP, Recipients, IFU None None
03/15/2021 bioMérieux SA VIDAS SARS-CoV-2 IgG
08/06/2020
IgG, ELFA H, M HCP, Recipients, IFU None None
08/17/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgG and IgM Combo Test
08/17/2020
IgM and IgG, CLIA H, M HCP, Recipients, IFU None None
08/17/2020 Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit
08/17/2020
IgM, CLIA H, M HCP, Recipients, IFU None None
08/25/2020 Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test - Letter of Authorization
08/25/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
08/31/2020 TBG Biotechnology Corp. TBG SARS-CoV-2 IgG / IgM Rapid Test Kit
08/31/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
08/31/2020 University of Arizona Genetics Core for Clinical Services COVID-19 ELISA pan-Ig Antibody Test
08/31/2020
Total Antibody, ELISA H HCP, Recipients, EUA Summary None None
04/23/2021 Sugentech, Inc. SGTi-flex COVID-19 IgG
09/03/2020
IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None None
09/09/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test Kit
09/09/2020
IgM, CLIA H, M HCP, Recipients, IFU None None
09/09/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgG Antibody Test Kit
09/09/2020
IgG, CLIA H, M HCP, Recipients, IFU None None
09/14/2020 Shenzhen New Industries Biomedical Engineering Co., Ltd. MAGLUMI 2019-nCoV IgM/IgG
09/14/2020
IgM and IgG, CLIA H, M HCP, Recipients, IFU None None
11/10/2020 Jiangsu Well Biotech Co., Ltd. Orawell IgM/IgG Rapid Test
09/23/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU
  • INDICAID COVID-19 IgM/IgG Rapid Test
04/27/2021 Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine
09/25/2020
Total Antibody, photometric immunoassay H HCP, Recipients, IFU None
09/29/2020 DiaSorin, Inc. DiaSorin LIAISON SARS-CoV-2 IgM Assay
09/29/2020
IgM, Indirect CLIA H, M HCP, Recipients, IFU None None
09/29/2020 NanoEntek America, Inc. FREND COVID-19 total Ab
09/29/2020
Total Antibody, FIA H, M HCP, Recipients, IFU None None
09/29/2020 Nirmidas Biotech, Inc. Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
09/29/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
10/06/2020 Thermo Fisher Scientific OmniPATH COVID-19 Total Antibody ELISA Test
10/02/2020
Total Antibody, ELISA H, M HCP, Recipients, IFU None None
10/06/2020 ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 IgG Test System
10/06/2020
IgG, ELISA H, M HCP, Recipients, IFU None None
10/08/2020 Beckman Coulter, Inc. Access SARS-CoV-2 IgM
10/08/2020
IgM, CLIA H, M HCP, Recipients, IFU None None
10/08/2020 Genalyte, Inc. Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
10/08/2020
Total Antibody, photonic ring immunoassay H, M HCP, Recipients, IFU None None
10/09/2020 Abbott Laboratories Inc. AdviseDx SARS-CoV-2 IgM 10/09/2020 IgM, CMIA H, M

HCP, Recipients,   IFU-ARCHITECTIFU-Alinityi

None None
10/28/2020 Quansys Biosciences, Inc. Q-Plex SARS-CoV-2 Human IgG (4 Plex) 10/28/2020 IgG, CLIA H HCP, Recipients, IFU None None
11/06/2020 GenScript USA Inc. cPass SARS-CoV-2 Neutralization Antibody Detection Kit 11/06/2020 Total Neutralizing Antibodies, Blocking ELISA H HCP, Recipients, IFU None None
11/24/2020 Kantaro Biosciences, LLC COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit
11/24/2020
IgG, ELISA, Semi-quantitative H HCP, Recipients, IFU None None
05/06/2021 Roche Diagnostics, Inc. Elecsys Anti-SARS-CoV-2 S
11/25/2020
Total Antibody, ECLIA, Semi-quantitative H, M HCP, Recipients, IFU None
11/23/2020 Innovita (Tangshan) Biological Technology Co., Ltd. Innovita 2019-nCoV Ab Test (Colloidal Gold)
11/23/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
12/15/2020 ACON Laboratories, Inc. ACON SARS-CoV-2 IgG/IgM Rapid Test
12/15/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
04/15/2021 Quanterix Corporation Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test
12/23/2020
IgG, Paramagnetic Microbead-based Sandwich ELISA, Semi-quantitative H, M HCP, Recipients, IFU None
04/12/2021 Nirmidas Biotech, Inc. MidaSpot COVID-19 Antibody Combo Detection Kit
12/31/2020
IgM and IgG, lateral flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU

None

04/02/2021 Siemens Healthcare Diagnostics Inc. Dimension EXL SARS‑CoV‑2 IgG (CV2G)
01/08/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None
04/02/2021 Siemens Healthcare Diagnostics Inc. Dimension Vista SARS‑CoV‑2 IgG (COV2G)
01/08/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None
04/26/2021 ADVAITE, Inc. RapCov Rapid COVID-19 Test
01/11/2021
IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None
01/19/2021 Phadia AB EliA SARS-CoV-2-Sp1 IgG Test
01/11/2021
IgG, Fluoroenzyme Immunoassay, Semi-quantitative H, M HCP, Recipients, IFU None None
01/15/2021 United Biomedical, Inc. UBI SARS-CoV-2 ELISA
01/15/2021
IgG, ELISA H HCP, Recipients, IFU None None
02/10/2021 Immunodiagnostic Systems Ltd. IDS SARS-CoV-2 IgG
02/10/2021
IgG, CLIA H, M HCP, Recipients, IFU None None
03/15/2021 Abbott Laboratories Inc. AdviseDx SARS-CoV-2 IgG II
03/01/2021
IgG, CMIA, Semi-quantitative H, M HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi None None
03/15/2021 Adaptive Biotechnologies Corporation T-Detect COVID Test
03/05/2021
T-cell receptor beta (TCR β), Sequencing H HCP, Recipients, EUA Summary None None
03/25/2021 Beckman Coulter, Inc. Access SARS-CoV-2 IgG II
03/22/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None None
04/01/2021 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 IgG (sCOVG)
03/23/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None None
04/05/2021 Symbiotica, Inc. COVID-19 Self-Collected Antibody Test System
04/05/2021
IgG, ELISA, Home Collection, Fingerstick Dried Blood Spot H HCP, Recipients, EUA Summary, IFU (Home Collect) None None
04/19/2021 Inova Diagnostics, Inc. QUANTA Flash SARS-CoV-2 IgG
04/19/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None None

1 Authorized settings include the following:

  • H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
  • M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
  • W - Patient care settings operating under a CLIA Certificate of Waiver.

2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

3 Abbreviations: CLIA = chemiluminescence immunoassay; ELISA = enzyme-linked immunosorbent assay; ECLIA = electrochemiluminescence immunoassay; FMIA = fluorescent microsphere Immunoassay, CMIA = chemiluminescent microparticle immunoassay; ELFA = enzyme-linked fluorescence assay


Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2

On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by the FDA, and are confirmed by the FDA to meet the criteria set forth in the Scope of Authorization of the EUA.  To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization.

On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA.

Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

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