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:
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
In Vitro Diagnostic EUAs: Overview and Templates
- COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
- Templates and Other Information
- Molecular Diagnostic Tests for SARS-CoV-2
- Antigen Diagnostic Tests for SARS-CoV-2
- Other Tests for SARS-CoV-2
- IVDs for Management of COVID-19 Patients
On This Page:
- Individual EUAs for Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- Revision Concerning Viral Mutation
- Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2
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 |
| |
| 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 | |
| 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 |
| |
| 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 |
| |
| 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 |
| |
| 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 |
| |
| 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 |
| |
| 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 |
| |
| 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 | |
| 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-ARCHITECT, IFU-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 | |
| 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 | HCP, Recipients, 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.