In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2
August 11, 2026 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.
The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act.
On June 29, 2026, the HHS Secretary determined that circumstances no longer exist justifying the authorization of emergency use of (1) in vitro diagnostics for detection and/or diagnosis of the SARS-CoV-2 virus; (2) personal respiratory protective devices; and (3) medical devices, including alternative products used as medical devices. On the basis of this determination, the HHS declarations authorizing emergency use of these medical devices for COVID-19 will be terminated, effective December 26, 2026. On the effective date of this termination, the COVID-19 emergency use authorizations (EUA) for devices currently listed on this website will no longer be in effect.
The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end . Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
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
- Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- IVDs for Management of COVID-19 Patients
On This Page:
- Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2
- Individual EUAs for Genotyping Tests for SARS-CoV-2
Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 diagnostic tests that analyze breath samples and have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and the settings authorized to use the EUA product. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column.
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 breath tests for the detection of volatile organic compounds associated with SARS-CoV-2 infection are assigned the QSH product code.
| Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes | Authorized Setting(s)1 | Authorization Documents2 | Other Brand Name(s) |
|---|---|---|---|---|---|---|
| 04/14/2022 | InspectIR Systems LLC | InspectIR COVID-19 Breathalyzer 04/14/2022 | Rapid gas chromatography-mass spectrometry (GC-MS), Five Volatile Organic Compounds (VOCs), Screening | Near Patient/Point-of-Care | HCP, Patients, IFU | None |
1 Authorized settings noted as 'Near Patient/Point-of-Care' include environments where the patient specimen is both collected and analyzed and the test is performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests.
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.
Individual EUAs for Genotyping Tests for SARS-CoV-2
This table includes information about authorized SARS-CoV-2 genotyping tests that have been authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages and/or for the identification of specific SARS-CoV-2 mutations. These EUAs have been issued for each individual test with certain conditions of authorization, including those required of the manufacturer, and the settings authorized to use the EUA product. Test attributes are listed in the "Attributes" column.
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 SARS-CoV-2 genotyping tests are assigned the QTA product code.
| Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
|---|---|---|---|---|---|---|---|
| 12/06/2023 | Laboratory Corporation of America (Labcorp) | Clear Dx SARS-CoV-2 WGS v3.0 Test 08/01/2023 | Next Generation Sequencing (NGS), PANGO lineage | H | HCP, Patients, EUA Summary | None | |
| 06/10/2022 | Laboratory Corporation of America (Labcorp) | Labcorp VirSeq SARS-CoV-2 NGS Test 06/10/2022 | Next Generation Sequencing (NGS), PANGO lineage | H | HCP, Patients, EUA Summary | None | None |
1Authorized 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.