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  1. COVID-19 Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics Emergency Use Authorizations (EUAs) - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2

March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for: 

  • Developing a transition implementation plan, 
  • Submitting a marketing submission, and 
  • Taking other actions with respect to these devices. 

The FDA encourages stakeholders to review the two final guidances, view the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances. 

Additional Resources: 

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

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.

For information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).

In addition to COVID-19 tests issued EUAs, there are serology SARS-CoV-2 tests that have been authorized through traditional premarket review pathways.

To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for each EUA.

Authorized devices in the table below are assigned the QKO product code.

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)
05/31/2022 LG Chem, Ltd. AdvanSure SARS-CoV-2 IgG(RBD) ELISA 
05/31/2022
IgG, ELISA H HCP, Recipients, IFU None None
05/19/2022 LG Chem, Ltd. AdvanSure SARS-CoV-2 IgG(S1) ELISA
05/19/2022
IgG, ELISA H HCP, Recipients, IFU None None
03/01/2022 EUROIMMUN US, Inc. EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG)
10/04/2021
IgG, ELISA, Semi-quantitative H, M HCP, Recipients, IFU None
08/24/2021 InBios International, Inc SCoV-2 Detect IgG Rapid Test
08/24/2021
IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None None
05/24/2022 Abbott Laboratories Inc. SARS-CoV-2 IgG assay
04/26/2020
IgG, CMIA H, M HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi None
04/15/2020 Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test
04/15/2020
IgG, ELISA H HCP, Patients, EUA Summary None
10/07/2021 DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG
04/24/2020
IgG, CLIA H, M HCP, Recipients, IFU None
02/25/2022 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
07/13/2021 Roche Diagnostics Elecsys Anti-SARS-CoV-2
05/02/2020
Total Antibody, ECLIA H, M HCP, Recipients, IFU None
02/09/2022 EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG)
05/04/2020
IgG, ELISA H HCP, Recipients, IFU None
01/26/2022 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
06/01/2021 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 Total (COV2T)
05/29/2020
Total Antibody, CLIA, Semi-quantitative  H, M HCP, Recipients, IFU None
09/14/2021 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 Total (COV2T)
05/29/2020
Total Antibody, CLIA, Semi-quantitative 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
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
01/18/2022 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
01/18/2022 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
05/14/2021 InBios International, Inc. SCoV-2 Detect IgG ELISA
06/10/2020
IgG, ELISA H, M HCP, Recipients, IFU None
04/21/2022 Emory Medical Laboratories SARS-CoV-2 RBD IgG test
06/15/2020
IgG, ELISA H HCP, Recipients, EUA Summary None
12/16/2021 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
02/14/2022 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 None
12/17/2021 Beckman Coulter, Inc. Access SARS-CoV-2 IgG
06/26/2020
IgG, CLIA H, M HCP, Recipients, IFU None
03/25/2021 InBios International, Inc. SCoV-2 Detect IgM ELISA
06/30/2020
IgM, ELISA H HCP, Recipients, IFU None
01/31/2022 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
  • Ecotest COVID-19 IgG/IgM Rapid Test Device
  • Fastep COVID-19 IgG/IgM Rapid Test Device
01/18/2022 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
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
07/12/2021 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
  • Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
  • Sienna COVID-19 IgG/IgM Rapid Test Cassette
03/09/2022 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
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
08/12/2021 Access Bio, Inc. CareStart COVID-19 IgM/IgG
07/24/2020
IgM and IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU
  • Rapid Response Liberty COVID-19 IgG/IgM
  • KarmaCare SARS-CoV-2 IgM/IgG
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
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
01/18/2022 Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit
08/17/2020
IgM, CLIA H, M HCP, Recipients, IFU None
08/25/2020 Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test
08/25/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU 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
11/19/2021 Sugentech, Inc. SGTi-flex COVID-19 IgG
09/03/2020
IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU
  • TekiTrust COVID-19 IgG
09/09/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test Kit
09/09/2020
IgM, CLIA H, M HCP, Recipients, IFU 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
12/16/2021 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
03/01/2022 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
12/13/2021 NanoEntek America, Inc. FREND COVID-19 total Ab
09/29/2020
Total Antibody, FIA H, M HCP, Recipients, IFU 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
12/08/2021 ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 IgG Test System
10/06/2020
IgG, ELISA H, M HCP, Recipients, IFU None
12/13/2021 Beckman Coulter, Inc. Access SARS-CoV-2 IgM
10/08/2020
IgM, CLIA H, M HCP, Recipients, IFU 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
10/01/2021 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

02/01/2022

GenScript USA Inc. cPass SARS-CoV-2 Neutralization Antibody Detection Kit
11/06/2020
Total Neutralizing Antibodies, Blocking ELISA, Semi-quantitative H HCP, Recipients, IFU 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
08/24/2022 Roche Diagnostics, Inc. Elecsys Anti-SARS-CoV-2 S
11/25/2020
Total Antibody, ECLIA, Semi-quantitative H, M HCP, Recipients, IFU None
07/21/2022 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
12/15/2021 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
11/02/2021 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

03/04/2022 Siemens Healthcare Diagnostics Inc. Dimension EXL SARS‑CoV‑2 IgG (CV2G)
01/08/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None
03/04/2022 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
01/15/2021 United Biomedical, Inc. UBI SARS-CoV-2 ELISA
01/15/2021
IgG, ELISA H HCP, Recipients, IFU None
12/09/2021 Immunodiagnostic Systems Ltd. IDS SARS-CoV-2 IgG
02/10/2021
IgG, CLIA H, M HCP, Recipients, IFU None
06/07/2024 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
07/21/2022 Adaptive Biotechnologies Corporation T-Detect COVID Test
03/05/2021
T-cell receptor beta (TCR β), Sequencing H HCP, Recipients, EUA Summary None
08/18/2021 Beckman Coulter, Inc. Access SARS-CoV-2 IgG II
03/22/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None None
01/19/2022 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
06/24/2021 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
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
12/13/2021 ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 Total Antibody Test System
05/11/2021
Total Antibody, ELISA H, M HCP, Recipients, IFU None
02/28/2022 QIAGEN, GmbH QIAreach Anti-SARS-CoV-2 Total Test
05/11/2021
Total Antibody, Digital Lateral Flow H, M HCP, Recipients, IFU None
05/19/2021 DiaSorin, Inc. LIAISON SARS-CoV-2 TrimericS IgG
05/19/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None
02/01/2022 NOWDiagnostics, Inc. ADEXUSDx COVID-19 Test
05/24/2021
Total Antibody, Lateral Flow, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None None
08/10/2021 Diabetomics, Inc. CovAb SARS-CoV-2 Ab Test
06/04/2021
Total Antibody, Lateral Flow, Oral Fluid H, M, W HCP, Recipients, IFU None None
08/10/2021 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 IgG (sCOVG)
06/17/2021
IgG, CLIA, Semi-quantitative H, M HCP, Recipients, IFU None
06/24/2021 Access Bio, Inc. CareStart EZ COVID-19 IgM/IgG
06/24/2021
IgM and IgG, Lateral Flow, Fingerstick Whole Blood H, M, W HCPRecipients, IFU None
07/13/2022 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator
07/09/2021
IgG, CLIA, Quantitative H, M HCP, Recipients, IFU None
09/21/2023 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
07/22/2021
Total Antibody, CLIA H, M HCP, Recipients, IFU None
08/31/2022 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ab Test
08/02/2021
Total Antibody, Fluorescence Immunoassay, Fingerstick Whole Blood H, M, W HCP, Recipients, IFU None
10/22/2021 InBios International, Inc. SCoV-2 Detect Neutralizing Ab ELISA
10/22/2021
Total Neutralizing Antibodies, ELISA H HCP, Recipients, IFU None None
12/06/2022 Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit
12/06/2022
Total Neutralizing Antibodies, CLIA 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


Revision Concerning Viral Mutations

On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test's performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.


The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s).  If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

Viral Mutation Revision Letter – September 23, 2021


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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